Soft Rib Fracture Orthosis Suppliers
Limit companies to: Worldwide USA
DJO Incorporated | Address: 1430 Decision Street, Vista, California 92081-8553, USA 
www.djoglobal.com | Phone: +1-(760)-727-1280, 800-336-6569
FDA Registration: 2020737 Year Established: 1978 Employee Count: ~4000
Products: Ankle Braces, Knee Braces, Cuffing System, Orthopedic knee Braces, Orthopaedic Implants, Ankle Braces & Supports, ...
DJO Incorporated is a provider of orthopedic devices. We offer a wide range of products used for rehabilitation, pain management and physical therapy. We also develop, manufacture and distribute a bro more...
www.djoglobal.com | Phone: +1-(760)-727-1280, 800-336-6569
FDA Registration: 2020737 Year Established: 1978 Employee Count: ~4000
Products: Ankle Braces, Knee Braces, Cuffing System, Orthopedic knee Braces, Orthopaedic Implants, Ankle Braces & Supports, ...
DJO Incorporated is a provider of orthopedic devices. We offer a wide range of products used for rehabilitation, pain management and physical therapy. We also develop, manufacture and distribute a bro more...
Scott Orthotic Labs, Inc. | Address: 1709 Heath Parkway, Fort Collins, Colorado 80524, USA
www.scottorthotic.com | Send Inquiry | Phone: +1-(970)-484-5017, 866-648-9148
Annual Revenues: > USD 1 Billion
Products: Custom Orthotics, Cranial Orthosis (FDA Code: MVA), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), External Brace Component Stirrup (FDA Code: ITC), External Brace Hip Joint (FDA Code: ITS), ...
Scott Orthotic Labs, Inc. is a manufacturer of prefabricated orthotics, prosthetic and orthotic components. Our orthotic components include thermoplastic ankle walkers, TLSO & LSO systems for cervical more...
www.scottorthotic.com | Send Inquiry | Phone: +1-(970)-484-5017, 866-648-9148
Annual Revenues: > USD 1 Billion
Products: Custom Orthotics, Cranial Orthosis (FDA Code: MVA), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), External Brace Component Stirrup (FDA Code: ITC), External Brace Hip Joint (FDA Code: ITS), ...
Scott Orthotic Labs, Inc. is a manufacturer of prefabricated orthotics, prosthetic and orthotic components. Our orthotic components include thermoplastic ankle walkers, TLSO & LSO systems for cervical more...
Tartan Orthopedics, Ltd. | Address: 10651 Irma Drive, Unit C, Northglenn, Colorado 80233, USA
www.tartanortho.com | Send Inquiry | Phone: +1-(303)-287-1456, 888-287-1456
Year Established: 1974 Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Cervical Collars, Adult Foot & Ankle Splints, Abdominal Binders (FDA Code: FSD), Acromioclavicular Splint, Clavicle Strap, Ankle Wraps, ...
Tartan Orthopedics, Ltd. provides abdominal binders, acromioclavicular splints, ankle splints, wraps, supports for the back,trochanter, lumbar, sacral and dorsal lumbar regions.We also supply cervical more...
www.tartanortho.com | Send Inquiry | Phone: +1-(303)-287-1456, 888-287-1456
Year Established: 1974 Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Cervical Collars, Adult Foot & Ankle Splints, Abdominal Binders (FDA Code: FSD), Acromioclavicular Splint, Clavicle Strap, Ankle Wraps, ...
Tartan Orthopedics, Ltd. provides abdominal binders, acromioclavicular splints, ankle splints, wraps, supports for the back,trochanter, lumbar, sacral and dorsal lumbar regions.We also supply cervical more...
Professional Products Inc | Address: 54 Hugh Adams Road, DeFuniak Springs, Florida 32435, USA
www.ezywrap.com | Phone: +1-(800)-234 9004
FDA Registration: 1026765 Year Established: 1958 Quality: CE Certified
Products: Ankle Braces, Elbow Braces, Cervico-Thoracic Braces, Back Braces & Supports, Ankle and Foot Braces, Ankle Braces & Supports, ...
Professional Products Inc develops orthopaedic medical products. We produce VelcroA® for designing bandages, wraps and elastic supports. We improve on post-operative and post-injury pain relief. W more...
www.ezywrap.com | Phone: +1-(800)-234 9004
FDA Registration: 1026765 Year Established: 1958 Quality: CE Certified
Products: Ankle Braces, Elbow Braces, Cervico-Thoracic Braces, Back Braces & Supports, Ankle and Foot Braces, Ankle Braces & Supports, ...
Professional Products Inc develops orthopaedic medical products. We produce VelcroA® for designing bandages, wraps and elastic supports. We improve on post-operative and post-injury pain relief. W more...
A&A Orthopedics, Inc. | Address: 12250 Sw 129th Court, Bldg. 01, Miami, Florida 33186, USA
www.aaorthopedics.com | Phone: +1-(305)-710-7416
FDA Registration: 1042714
Products: Adhesive Elastic Bandage Tape, Cohesive Elastic Bandage, Abdominal Binders (FDA Code: FSD), Bariatric Abdominal Binder, Cast Shoe (FDA Code: IPG), Clavicle Splint (FDA Code: IQJ), ...
A&A Orthopedics, Inc. specializes in offering anatomical supports. We are engaged in product development, manufacturing and distribution through healthcare professionals and approved distributors. Our more...
www.aaorthopedics.com | Phone: +1-(305)-710-7416
FDA Registration: 1042714
Products: Adhesive Elastic Bandage Tape, Cohesive Elastic Bandage, Abdominal Binders (FDA Code: FSD), Bariatric Abdominal Binder, Cast Shoe (FDA Code: IPG), Clavicle Splint (FDA Code: IQJ), ...
A&A Orthopedics, Inc. specializes in offering anatomical supports. We are engaged in product development, manufacturing and distribution through healthcare professionals and approved distributors. Our more...
FLA Orthopedics, Inc. | Address: 2881 Corporate Way, Miramar, Florida 33025-3973, USA
www.flaorthopedics.com | Send Inquiry | Phone: +1-(800)-327-4110
Year Established: 1975 Employee Count: ~200
Products: Splints, Back Braces & Supports, Collars, Compression Garments, Crutches, Canes, Walkers, Casting Materials, ...
FLA Orthopedics, Inc creates & produces orthopedic, sports medicine and bracing products, as well as occupational/ergonomic supports, compression hosiery, footcare products, seating & positioning whee more...
www.flaorthopedics.com | Send Inquiry | Phone: +1-(800)-327-4110
Year Established: 1975 Employee Count: ~200
Products: Splints, Back Braces & Supports, Collars, Compression Garments, Crutches, Canes, Walkers, Casting Materials, ...
FLA Orthopedics, Inc creates & produces orthopedic, sports medicine and bracing products, as well as occupational/ergonomic supports, compression hosiery, footcare products, seating & positioning whee more...
U.S. Orthotics, Inc. | Address: 8605 Palm River Road, Tampa, Florida 33619-4317, USA
www.usorthotics.com | Send Inquiry | Phone: +1-(813)-621-7797, 800-825-5228
FDA Registration: 1043533 Year Established: 1979 Annual Revenues: USD 1-5 Million Employee Count: ~50
Products: Elastic Ankle Support, Adjustable Ankle Support, Air Ankle Support, Basic Ankle Support, Double-Strap Ankle Support, Ankle Support, ...
U.S. Orthotics, Inc. specializes in the design, manufacturing, and servicing of orthopedic products. We offer traditional chair back orthosis with rigid anterior panel and soft foam lined rigid poster more...
www.usorthotics.com | Send Inquiry | Phone: +1-(813)-621-7797, 800-825-5228
FDA Registration: 1043533 Year Established: 1979 Annual Revenues: USD 1-5 Million Employee Count: ~50
Products: Elastic Ankle Support, Adjustable Ankle Support, Air Ankle Support, Basic Ankle Support, Double-Strap Ankle Support, Ankle Support, ...
U.S. Orthotics, Inc. specializes in the design, manufacturing, and servicing of orthopedic products. We offer traditional chair back orthosis with rigid anterior panel and soft foam lined rigid poster more...
Tetra Medical Supply Corporation | Address: 6364 West Gross Point Road, Niles, Illinois 60714, USA
www.tetramed.com | Send Inquiry | Phone: +1-(847)-647-0590, 800-621-4041
FDA Registration: 1418270 Year Established: 1913 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: General Medical Supplies, Wrist/Arm/Shoulder Braces & Supports, Adhesive Bandages (FDA Code: KGX), Adhesive Dressing, Bariatric Abdominal Binder, Panel Elastic Abdominal Binder, ...
Tetra Medical Supply Corporation focuses on bandages, dressings, orthopedic softgoods, and hot & cold therapy products. Our portfolio of customers includes hospitals, surgeons, podiatrists, chiropract more...
www.tetramed.com | Send Inquiry | Phone: +1-(847)-647-0590, 800-621-4041
FDA Registration: 1418270 Year Established: 1913 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: General Medical Supplies, Wrist/Arm/Shoulder Braces & Supports, Adhesive Bandages (FDA Code: KGX), Adhesive Dressing, Bariatric Abdominal Binder, Panel Elastic Abdominal Binder, ...
Tetra Medical Supply Corporation focuses on bandages, dressings, orthopedic softgoods, and hot & cold therapy products. Our portfolio of customers includes hospitals, surgeons, podiatrists, chiropract more...
Sroufe Healthcare Products, LLC | Address: 601 Sroufe St, PO Box 347, Ligonier, Indiana 46767, USA
www.sroufe.com | Send Inquiry | Phone: +1-(260)-894-4171
Year Established: 1975 Annual Revenues: USD 5-10 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Ankle Braces, Ankle and Foot Braces, Ankle Braces & Supports, Adjustable Ankle Support, 3-Panel Knee Immobilizer, Athletic Shoes, ...
Sroufe Healthcare Products is a supplier of cast boots, post-opearation shoes, orthopedic soft goods and accessories. We market Pneugel brand shoulder wraps, elbows, Pneugel accessories and knee suppo more...
www.sroufe.com | Send Inquiry | Phone: +1-(260)-894-4171
Year Established: 1975 Annual Revenues: USD 5-10 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Ankle Braces, Ankle and Foot Braces, Ankle Braces & Supports, Adjustable Ankle Support, 3-Panel Knee Immobilizer, Athletic Shoes, ...
Sroufe Healthcare Products is a supplier of cast boots, post-opearation shoes, orthopedic soft goods and accessories. We market Pneugel brand shoulder wraps, elbows, Pneugel accessories and knee suppo more...
Midwest Orthotic Services, LLC | Address: 17530 Dugdale Dr., South Bend, Indiana 46635, USA
www.midwestorthotics.com | Send Inquiry | Phone: +1-(574)-233-3352, 866-316-1312
FDA Registration: 3003895329
Products: Ankle Braces & Supports, Elbow Braces & Supports, Bone Growth Stimulators, Braces & Orthoses, Braces, Limb Brace Orthosis (FDA Code: IQI), ...
Midwest Orthotic Services, LLC specializes in orthotic and pedorthic healthcare. We provide all types of orthotic services. Our services include specialized pediatric services, custom bracing, prefabr more...
www.midwestorthotics.com | Send Inquiry | Phone: +1-(574)-233-3352, 866-316-1312
FDA Registration: 3003895329
Products: Ankle Braces & Supports, Elbow Braces & Supports, Bone Growth Stimulators, Braces & Orthoses, Braces, Limb Brace Orthosis (FDA Code: IQI), ...
Midwest Orthotic Services, LLC specializes in orthotic and pedorthic healthcare. We provide all types of orthotic services. Our services include specialized pediatric services, custom bracing, prefabr more...
Scott Specialties Inc | Address: 512 M Street, Belleville, Kansas 66935, USA
www.scottspecialties.com | Send Inquiry | Phone: +1-(800)-255 7136
FDA Registration: 1917910 Year Established: 1962 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: CE Certified
Products: Splints, Back Braces & Supports, Collars, Knee/Ankle Braces & Supports, General Medical Supplies, Rib & Abdomen Supports, ...
Scott Specialties Inc manufactures private label, OEM and branded orthopedic soft goods. We also supply sports medicine products. Our SA9001 neoprene thumb spica consists of blue plush neoprene for wa more...
www.scottspecialties.com | Send Inquiry | Phone: +1-(800)-255 7136
FDA Registration: 1917910 Year Established: 1962 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: CE Certified
Products: Splints, Back Braces & Supports, Collars, Knee/Ankle Braces & Supports, General Medical Supplies, Rib & Abdomen Supports, ...
Scott Specialties Inc manufactures private label, OEM and branded orthopedic soft goods. We also supply sports medicine products. Our SA9001 neoprene thumb spica consists of blue plush neoprene for wa more...
Lohmann & Rauscher, Inc. | Address: 6001 SW Sixth Avenue, Suite 101, Topeka, Kansas 66615-1004, USA
www.-lrmed.-com | Send Inquiry | Phone: +1-(785)-862-1100
Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), ...
Lohmann & Rauscher, Inc. offers a large variety from classic medical products to modern therapy-adjusted systems and system solutions. We offer various products for wound care, dressing retention, sup more...
www.-lrmed.-com | Send Inquiry | Phone: +1-(785)-862-1100
Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), ...
Lohmann & Rauscher, Inc. offers a large variety from classic medical products to modern therapy-adjusted systems and system solutions. We offer various products for wound care, dressing retention, sup more...
Dale Medical Products, Inc. | Address: P.O. Box 1556, 7 Cross Street, Plainville, Massachusetts 02762-0556, USA
www.dalemed.com | Send Inquiry | Phone: +1-(800)-343-3980
FDA Registration: 1214422 Year Established: 1961 Annual Revenues: USD 10-25 Million Employee Count: ~150
Products: Endotracheal Tubes, Compression Garments, General Diagnostic Supplies, General Medical Supplies, General Urology Supplies, Rib & Abdomen Supports, ...
Dale Medical Products, Inc. supplies post-surgical patient care products for the acute care hospital and long-term markets. Our product stabilock endotracheal tube holder provides fast and easy applic more...
www.dalemed.com | Send Inquiry | Phone: +1-(800)-343-3980
FDA Registration: 1214422 Year Established: 1961 Annual Revenues: USD 10-25 Million Employee Count: ~150
Products: Endotracheal Tubes, Compression Garments, General Diagnostic Supplies, General Medical Supplies, General Urology Supplies, Rib & Abdomen Supports, ...
Dale Medical Products, Inc. supplies post-surgical patient care products for the acute care hospital and long-term markets. Our product stabilock endotracheal tube holder provides fast and easy applic more...
Freeman | Address: 900 W. Chicago Road, Sturgis, Michigan 49091, USA
www.freemanmfg.com | Send Inquiry | Phone: +1-(269)-651-2371, 800-253-2091
FDA Registration: 1811757 Annual Revenues: USD 5-10 Million Employee Count: ~40
Products: Adult Foot & Ankle Splints, Adult Hand & Wrist Splints, Ankle Braces & Supports, Back Supports, Ankle Foot Orthosis, Ankle Support, ...
Freeman is a manufacturer of orthopedic softgoods to the global healthcare community. Our products range in diversity from a full line of back support garments and spinal braces to home healthcare pro more...
www.freemanmfg.com | Send Inquiry | Phone: +1-(269)-651-2371, 800-253-2091
FDA Registration: 1811757 Annual Revenues: USD 5-10 Million Employee Count: ~40
Products: Adult Foot & Ankle Splints, Adult Hand & Wrist Splints, Ankle Braces & Supports, Back Supports, Ankle Foot Orthosis, Ankle Support, ...
Freeman is a manufacturer of orthopedic softgoods to the global healthcare community. Our products range in diversity from a full line of back support garments and spinal braces to home healthcare pro more...
Accelerated Care Plus Corp. | Address: 4850 Joule Street, Bldg. A-1, Reno, Nevada 89502, USA
www.acplus.com | Send Inquiry | Phone: +1-(775)-685-4000, 800-350-1100
FDA Registration: 1911273
Products: Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Arm Sling with Foam Strap, Arm Sling Strap Pads, Arm Sling Immobilizer, Abdominal Orthosis (FDA Code: KTD), ...
Accelerated Care Plus Corp. is a provider of specialized rehabilitation programs for long-term care facility operators and rehabilitation service providers. Our programs provide proprietary, patented more...
www.acplus.com | Send Inquiry | Phone: +1-(775)-685-4000, 800-350-1100
FDA Registration: 1911273
Products: Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Arm Sling with Foam Strap, Arm Sling Strap Pads, Arm Sling Immobilizer, Abdominal Orthosis (FDA Code: KTD), ...
Accelerated Care Plus Corp. is a provider of specialized rehabilitation programs for long-term care facility operators and rehabilitation service providers. Our programs provide proprietary, patented more...
Texas Orthopaedic Products & Services, L.L.C. | Address: 805 Riding Club Road, P.O. BOX 190, Rowlett, Texas 75087-2193, USA
topsproducts.com | Phone: +1-(972)-772-8776, 888-373-4009
Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Adhesive Elastic Bandage Tape, Abdominal Binders (FDA Code: FSD), Arm Sling Strap Pads, Arm Sling Immobilizer, Abdominal Orthosis (FDA Code: KTD), Ankle Stabilizer, ...
Texas Orthopaedic Products & Services, L.L.C. designs and manufactures an extensive line of orthopedic soft goods, braces, immobilizers, sports injury products, and related items that stabilize,and tr more...
topsproducts.com | Phone: +1-(972)-772-8776, 888-373-4009
Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Adhesive Elastic Bandage Tape, Abdominal Binders (FDA Code: FSD), Arm Sling Strap Pads, Arm Sling Immobilizer, Abdominal Orthosis (FDA Code: KTD), Ankle Stabilizer, ...
Texas Orthopaedic Products & Services, L.L.C. designs and manufactures an extensive line of orthopedic soft goods, braces, immobilizers, sports injury products, and related items that stabilize,and tr more...
La Pointique International Ltd. | Address: 1030 Industry Dr., No. 32-C, Tukwila, Washington 98188, USA
www.lp-support.com | Send Inquiry | Phone: +1-(206)-5758843
FDA Registration: 3023471
Products: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Cast Bandage (FDA Code: ITG), Cervical Orthosis (FDA Code: IQK), Clavicle Splint (FDA Code: IQJ), ...
La Pointique International Ltd. develops products for body parts protection and sports protection. Our products include coolprene®, nanometer and Maxwrap®. Our coolprene® is based on theor more...
www.lp-support.com | Send Inquiry | Phone: +1-(206)-5758843
FDA Registration: 3023471
Products: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Cast Bandage (FDA Code: ITG), Cervical Orthosis (FDA Code: IQK), Clavicle Splint (FDA Code: IQJ), ...
La Pointique International Ltd. develops products for body parts protection and sports protection. Our products include coolprene®, nanometer and Maxwrap®. Our coolprene® is based on theor more...
Darco International, Inc. | Address: 810 Memorial Blvd., Huntington, West Virginia 25701, USA
www.darcointernational.com | Send Inquiry | Phone: +1-(304)-522-4883
FDA Registration: 3006026111 Year Established: 1985 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Crutches, Canes, Walkers, Insoles & Footwear, Knee/Ankle Braces & Supports, General Medical Supplies, General Orthopedic Supplies, Shoes & Boots, ...
Darco International Inc manufactures orthopedic soft goods in the medical/surgical industry. The all purpose boot can be used as a post operative shoe and a cast boot. The closed toe protection allows more...
www.darcointernational.com | Send Inquiry | Phone: +1-(304)-522-4883
FDA Registration: 3006026111 Year Established: 1985 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Crutches, Canes, Walkers, Insoles & Footwear, Knee/Ankle Braces & Supports, General Medical Supplies, General Orthopedic Supplies, Shoes & Boots, ...
Darco International Inc manufactures orthopedic soft goods in the medical/surgical industry. The all purpose boot can be used as a post operative shoe and a cast boot. The closed toe protection allows more...
Lu Lu Sports Corp. | Address: 11 Tsu-Chiang Road, Nankang Ind. Park, Nan-Tou 540, Taiwan 
Phone: +886-(49)-226-2986
FDA Registration: 3003893701
Products: Lumbar Orthosis, Brace (FDA Code: IQE), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), External Brace Knee Joint (FDA Code: ITQ), Limb Cover (FDA Code: IPM), ...
Lu Lu Sports Corp. offers arm slings, arm supports, cast shoes, cervical orthosis, clavicle splints and crutches. We provide external ankle braces, brace knee joints and external inflatable extremity more...
Phone: +886-(49)-226-2986
FDA Registration: 3003893701
Products: Lumbar Orthosis, Brace (FDA Code: IQE), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), External Brace Knee Joint (FDA Code: ITQ), Limb Cover (FDA Code: IPM), ...
Lu Lu Sports Corp. offers arm slings, arm supports, cast shoes, cervical orthosis, clavicle splints and crutches. We provide external ankle braces, brace knee joints and external inflatable extremity more...
Jiundar Industrial Co., Ltd. | Address: No.9, Alley 2, Lane 252, San Jiun Street, Shulin City 238, Taiwan
www.jiundar.com.tw | Send Inquiry | Phone: +886-(02)-2689-2907
FDA Registration: 3003855936
Products: Foams, Sports Medicine, Elastic Bandages (FDA Code: FQM), Medical Fabrics Products, Cast Shoe (FDA Code: IPG), Sports Medicine Apparels, ...
Jiundar Industrial Co., Ltd. specializes in the lamination of industrial fabric used in sports medicine and garments. Our products include laminate product, TPU foam and TPU heat melt. Our TPU film is more...
www.jiundar.com.tw | Send Inquiry | Phone: +886-(02)-2689-2907
FDA Registration: 3003855936
Products: Foams, Sports Medicine, Elastic Bandages (FDA Code: FQM), Medical Fabrics Products, Cast Shoe (FDA Code: IPG), Sports Medicine Apparels, ...
Jiundar Industrial Co., Ltd. specializes in the lamination of industrial fabric used in sports medicine and garments. Our products include laminate product, TPU foam and TPU heat melt. Our TPU film is more...
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FDA Code / Regulation: IPX / 890.3490
A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.
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