Pelvic Support Band Suppliers
Limit companies to: Worldwide USA
Special Protectors Co., Ltd. | Address: 2FL., No. 130, Shin Hu 3rd Road,Nei Hu District, Taipei 114, Taiwan 
www.sp-supports.com | Send Inquiry | Phone: +886-(2)-27921812
FDA Registration: 9616914 Year Established: 1985 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001, ISO 9002, CE Certified
Products: Cervicothoracic Lumbar Orthosis, Adjustable Ankle Support, Air Ankle Support, Basic Ankle Support, Lumbar Orthosis, Brace (FDA Code: IQE), Ankle Support, ...
Special Protectors Co., Ltd. is a manufacturer of support products. Our products include abdominal belts, abdominal belts for support, belts-orthopedic, arm sling, cervical collars, clavicle, brace do more...
www.sp-supports.com | Send Inquiry | Phone: +886-(2)-27921812
FDA Registration: 9616914 Year Established: 1985 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001, ISO 9002, CE Certified
Products: Cervicothoracic Lumbar Orthosis, Adjustable Ankle Support, Air Ankle Support, Basic Ankle Support, Lumbar Orthosis, Brace (FDA Code: IQE), Ankle Support, ...
Special Protectors Co., Ltd. is a manufacturer of support products. Our products include abdominal belts, abdominal belts for support, belts-orthopedic, arm sling, cervical collars, clavicle, brace do more...
E-Life International Co., Ltd | Address: 4 F-3, No. 366, Zhonghe Rd., Zhonghe City 235, Taiwan
www.e-lifebracing.com | Send Inquiry | Phone: +886-(2)-29231516
FDA Registration: 3005885000 Quality: DIN ISO 9001 standard Certified
Products: 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), Temporary Training Splint (FDA Code: IQM), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
E-Life International Co., Ltd is involved in the business of orthopedic braces and supports. We produce orthopedic products, such as functional knees, ankles, elbows, wrists, walkings, back & spine br more...
www.e-lifebracing.com | Send Inquiry | Phone: +886-(2)-29231516
FDA Registration: 3005885000 Quality: DIN ISO 9001 standard Certified
Products: 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), Temporary Training Splint (FDA Code: IQM), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
E-Life International Co., Ltd is involved in the business of orthopedic braces and supports. We produce orthopedic products, such as functional knees, ankles, elbows, wrists, walkings, back & spine br more...
Maxtek Go-Go Co., Ltd. | Address: 7F, No.196, Sec 2, Chung-Hsin Rd, Hsin-Tien, Taipei 231, Taiwan
www.maxtek-go-go.com | Phone: +886-(2)-29176675
Products: Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Breast Binder (FDA Code: HEF), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Pelvic Support Band (FDA Code: ISR), ...
Maxtek Go-Go Co., Ltd. is an electronics device sales and service company. We distribute electronics devices for various applications in the fields of industry and medicine. Our smart body massage sys more...
www.maxtek-go-go.com | Phone: +886-(2)-29176675
Products: Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Breast Binder (FDA Code: HEF), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Pelvic Support Band (FDA Code: ISR), ...
Maxtek Go-Go Co., Ltd. is an electronics device sales and service company. We distribute electronics devices for various applications in the fields of industry and medicine. Our smart body massage sys more...
Pani Teresa Medica Sa | Address: Gutowo Male, Ul. Powidzka 50, Wrzesnia 62-300, Poland
www.pani-teresa.com.pl | Send Inquiry | Phone: +48-(61)-4388200
Quality: ISO 9001:2000 Certified
Products: Elastic Bandages (FDA Code: FQM), Medical Support Stocking (FDA Code: FQL), External Brace Knee Joint (FDA Code: ITQ), Limb Brace Orthosis (FDA Code: IQI), Overhead Supported Arm Sling (FDA Code: ILE), Hernia Support (FDA Code: EXN), ...
Pani Teresa Medica Sa manufactures textile and knitted medical products used in medical care & prophylaxis. We also provide pharmaceutical and orthopedic products. Our ventilated abdominal belt protec more...
www.pani-teresa.com.pl | Send Inquiry | Phone: +48-(61)-4388200
Quality: ISO 9001:2000 Certified
Products: Elastic Bandages (FDA Code: FQM), Medical Support Stocking (FDA Code: FQL), External Brace Knee Joint (FDA Code: ITQ), Limb Brace Orthosis (FDA Code: IQI), Overhead Supported Arm Sling (FDA Code: ILE), Hernia Support (FDA Code: EXN), ...
Pani Teresa Medica Sa manufactures textile and knitted medical products used in medical care & prophylaxis. We also provide pharmaceutical and orthopedic products. Our ventilated abdominal belt protec more...
Hankooknano Medical Co., Ltd | Address: No. 1631-11, Songjeong-Dong, Gangseo-Gu 618-819, Korea, Republic Of 
Phone: +82-(51)-7581935
Products: Manual Beds (FDA Code: FNJ), Disposable Hot/Cold Pack (FDA Code: IMD), Manual Therapeutic Massager (FDA Code: LYG), Powered Heating Pad (FDA Code: IRT), Electric Therapeutic Massager (FDA Code: ISA), Therapeutic Vibrator (FDA Code: IRO), ...
Hankooknano Medical Co., Ltd specializes in abdominal orthosis and disposable hot and cold pack. We provide manual beds, manual therapeutic massager, pelvic support band, powered heating pad, reusable more...
Phone: +82-(51)-7581935
Products: Manual Beds (FDA Code: FNJ), Disposable Hot/Cold Pack (FDA Code: IMD), Manual Therapeutic Massager (FDA Code: LYG), Powered Heating Pad (FDA Code: IRT), Electric Therapeutic Massager (FDA Code: ISA), Therapeutic Vibrator (FDA Code: IRO), ...
Hankooknano Medical Co., Ltd specializes in abdominal orthosis and disposable hot and cold pack. We provide manual beds, manual therapeutic massager, pelvic support band, powered heating pad, reusable more...
Saehan Corporation | Address: 973 Yangduk-Dong, Masan, Kyungsangnam-Do 630-728, Korea, Republic Of
Phone: +82-(11)-282-0161, 55-294-0381
FDA Registration: 8040255 Quality: CE mark Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Limb Brace Orthosis (FDA Code: IQI), Mechanical Table (FDA Code: INW), Water Circulating Hot/Cold Pack (FDA Code: ILO), ...
Saehan Corporation is a producer of digitized and computerized hand dynamometer. Our product line includes hand evaluation kits 3 Pcs & 7 Pcs, hydraulic hand dynamometer, hydraulic pinch guage, Digi-I more...
Phone: +82-(11)-282-0161, 55-294-0381
FDA Registration: 8040255 Quality: CE mark Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Limb Brace Orthosis (FDA Code: IQI), Mechanical Table (FDA Code: INW), Water Circulating Hot/Cold Pack (FDA Code: ILO), ...
Saehan Corporation is a producer of digitized and computerized hand dynamometer. Our product line includes hand evaluation kits 3 Pcs & 7 Pcs, hydraulic hand dynamometer, hydraulic pinch guage, Digi-I more...
Hankook Medical Co., Ltd | Address: Nambu-Dong 472-24, Yangsan-City, KR-48 626-010, Korea, Republic Of
Products: Manual Beds (FDA Code: FNJ), Disposable Hot/Cold Pack (FDA Code: IMD), Manual Therapeutic Massager (FDA Code: LYG), Powered Heating Pad (FDA Code: IRT), Electric Therapeutic Massager (FDA Code: ISA), Therapeutic Vibrator (FDA Code: IRO), ...
Hankook Medical Co., Ltd specializes in medical equipment. more...
Products: Manual Beds (FDA Code: FNJ), Disposable Hot/Cold Pack (FDA Code: IMD), Manual Therapeutic Massager (FDA Code: LYG), Powered Heating Pad (FDA Code: IRT), Electric Therapeutic Massager (FDA Code: ISA), Therapeutic Vibrator (FDA Code: IRO), ...
Hankook Medical Co., Ltd specializes in medical equipment. more...
Calzificio Pinelli Srl | Address: Via Germania 11, Castel Goffredo, Mantova 46042, Italy
Phone: +39-(0376)-788411
FDA Registration: 3007084481
Products: Medical Support Stocking (FDA Code: FQL), Pelvic Support Band (FDA Code: ISR), ...
Calzificio Pinelli Srl offers medical support stockings and pelvic support bands. more...
Phone: +39-(0376)-788411
FDA Registration: 3007084481
Products: Medical Support Stocking (FDA Code: FQL), Pelvic Support Band (FDA Code: ISR), ...
Calzificio Pinelli Srl offers medical support stockings and pelvic support bands. more...
Safte S.P.A. | Address: Via Adamello, 13, Borgata Paradiso Di Collegno, TO 10097, Italy
www.safte-italia.com | Send Inquiry | Phone: +39-(11)-403.81.11
Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9002, CE Certified
Products: Adjustable Back Support, Back Support Belt, Back Supports, Body Production, Back Support Standard, Back Support for Women, Lumbosacral Back Support, ...
Safte S.P.A. is engaged in the manufacture and distribution of textile orthopedic products. We provide a wide range of orthopedic soft goods. more...
www.safte-italia.com | Send Inquiry | Phone: +39-(11)-403.81.11
Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9002, CE Certified
Products: Adjustable Back Support, Back Support Belt, Back Supports, Body Production, Back Support Standard, Back Support for Women, Lumbosacral Back Support, ...
Safte S.P.A. is engaged in the manufacture and distribution of textile orthopedic products. We provide a wide range of orthopedic soft goods. more...
Trulife Ltd. | Address: Unit 3 Cookstown Industrial, Estate, Tallaght, Dublin 24, Ireland
www.trulife.com | Send Inquiry | Phone: +353-(1)-4511755
FDA Registration: 9615374 Employee Count: ~20 Quality: ISO Certified
Products: Custom Walking Crutches, External Breast Prosthesis (FDA Code: KCZ), Support Gel Test (FDA Code: JZR), Skin Pressure Protector (FDA Code: FMP), Limb & Truncal Orthosis (FDA Code: MRI), Wheelchair Cushions (FDA Code: IMP), ...
Trulife Ltd. is engaged in the creation, development, manufacture and marketing of niche healthcare products. Our activities encompass orthopedics, prosthetics, breastcare and pressurecare products, a more...
www.trulife.com | Send Inquiry | Phone: +353-(1)-4511755
FDA Registration: 9615374 Employee Count: ~20 Quality: ISO Certified
Products: Custom Walking Crutches, External Breast Prosthesis (FDA Code: KCZ), Support Gel Test (FDA Code: JZR), Skin Pressure Protector (FDA Code: FMP), Limb & Truncal Orthosis (FDA Code: MRI), Wheelchair Cushions (FDA Code: IMP), ...
Trulife Ltd. is engaged in the creation, development, manufacture and marketing of niche healthcare products. Our activities encompass orthopedics, prosthetics, breastcare and pressurecare products, a more...
Narang Medical Limited | Address: Narang Tower, 46 Community Centre, Naraina Ph-I, New Delhi, Delhi 110028, India 
www.narang.com | Send Inquiry | Phone: +91-(11)-45554000, 25892020
FDA Registration: 9613910 Quality: ISO 9001:2000, ISO 13485:2003, CE and WHO Certified
Products: Adult Bedpans, Adult, Double-head Stethoscope, Aluminium Surgical Box, Adult Wheelchairs, Aluminum Pressure Steam Sterilizers, Air Way Tube, ...
Narang Medical Limited is a manufacturer & exporter of medical supplies, surgical instruments, hospital equipment, laboratory products, diagnostics and sundries. Our products include laryngoscope sets more...
www.narang.com | Send Inquiry | Phone: +91-(11)-45554000, 25892020
FDA Registration: 9613910 Quality: ISO 9001:2000, ISO 13485:2003, CE and WHO Certified
Products: Adult Bedpans, Adult, Double-head Stethoscope, Aluminium Surgical Box, Adult Wheelchairs, Aluminum Pressure Steam Sterilizers, Air Way Tube, ...
Narang Medical Limited is a manufacturer & exporter of medical supplies, surgical instruments, hospital equipment, laboratory products, diagnostics and sundries. Our products include laryngoscope sets more...
Apothecaries Sundries Mfg. Co. | Address: ASCO House, No. 13, Community Center, Mayapuri, Phase 1, New Delhi, Delhi 110064, India
www.ascoindia.com | Phone: +91-(11)-45645656
Quality: ISO 9001 Certified
Products: Anesthesia Equipment, Bone Plates, Cloverleaf, Cancellous Bone Screw, Black Rubber Formable Mask, Angle Blade Plate Instrument, Bedpan (FDA Code: FOB), ...
Apothecaries Sundries Mfg. Co. specializes in offering surgical/hospital appliances and allied products. Our products include anesthesia products, fiber glass models, operating tables & shadowless lam more...
www.ascoindia.com | Phone: +91-(11)-45645656
Quality: ISO 9001 Certified
Products: Anesthesia Equipment, Bone Plates, Cloverleaf, Cancellous Bone Screw, Black Rubber Formable Mask, Angle Blade Plate Instrument, Bedpan (FDA Code: FOB), ...
Apothecaries Sundries Mfg. Co. specializes in offering surgical/hospital appliances and allied products. Our products include anesthesia products, fiber glass models, operating tables & shadowless lam more...
Summitop Hk Industrial Co Ltd | Address: 11/f Block A Chung Mei Center, 15 Hing Yip Street Kwun Tong, Hong Kong 23000, Hong Kong 
www.summitop.com | Send Inquiry | Phone: +852-(0)-27997611
Products: Wheelchair Accessories (FDA Code: KNO), Lumbar Orthosis, Brace (FDA Code: IQE), Tracheal Tube Fixation Device (FDA Code: CBH), Clavicle Splint (FDA Code: IQJ), Limb Brace Orthosis (FDA Code: IQI), Colostomy Pouch (FDA Code: EZQ), ...
Summitop Hk Industrial Co Ltd is involved in the business of gloves. more...
www.summitop.com | Send Inquiry | Phone: +852-(0)-27997611
Products: Wheelchair Accessories (FDA Code: KNO), Lumbar Orthosis, Brace (FDA Code: IQE), Tracheal Tube Fixation Device (FDA Code: CBH), Clavicle Splint (FDA Code: IQJ), Limb Brace Orthosis (FDA Code: IQI), Colostomy Pouch (FDA Code: EZQ), ...
Summitop Hk Industrial Co Ltd is involved in the business of gloves. more...
Allmay International Limited | Address: Room 1405-6, 14/f, Fu Lee Commercial Building, 14-20 Pilkem Street, Jordan, Kowloon, Hong Kong
www.allmayltd.com | Send Inquiry | Phone: +852-(0)-23170418
FDA Registration: 3007109661
Products: Cervical Collars, Adjustable Knee Brace, Arm Slings (FDA Code: ILI), Clavicle Braces, Cast Shoe (FDA Code: IPG), External Ankle Brace (FDA Code: ITW), ...
Allmay International Limited provides orthopedic products to customers. Our products include cervical collar, neoprene shoulder support, adjustable rigid collar, clavicle brace, shoulder immobilizer, more...
www.allmayltd.com | Send Inquiry | Phone: +852-(0)-23170418
FDA Registration: 3007109661
Products: Cervical Collars, Adjustable Knee Brace, Arm Slings (FDA Code: ILI), Clavicle Braces, Cast Shoe (FDA Code: IPG), External Ankle Brace (FDA Code: ITW), ...
Allmay International Limited provides orthopedic products to customers. Our products include cervical collar, neoprene shoulder support, adjustable rigid collar, clavicle brace, shoulder immobilizer, more...
Winds Enterprises Ltd. | Address: 10/f., Suite 1001, Tower 5, Chkc, 33 Canton Road, Tsimshatsui, Hong Kong
Phone: +852-(0)-5094930
Products: Ice Bags (FDA Code: KYR), Arm Supports (FDA Code: IOY), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Pelvic Support Band (FDA Code: ISR), ...
Winds Enterprises Ltd. focuses on arm supports, external ankle braces, external brace knee joints, ice bags and pelvic support band. more...
Phone: +852-(0)-5094930
Products: Ice Bags (FDA Code: KYR), Arm Supports (FDA Code: IOY), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Pelvic Support Band (FDA Code: ISR), ...
Winds Enterprises Ltd. focuses on arm supports, external ankle braces, external brace knee joints, ice bags and pelvic support band. more...
Medical Z, S.A. | Address: Blavou St. Denis Sur Huisne, Mortagne Au Perche 61400, France
Phone: 332-33-73 77
FDA Registration: 8023033
Products: General Surgical Manual Instrument (FDA Code: MDM), Silicone Elastomer (FDA Code: MDA), Skin Pressure Protector (FDA Code: FMP), Therapeutic Medical Binder (FDA Code: MDR), Pelvic Support Band (FDA Code: ISR), Electric Therapeutic Massager (FDA Code: ISA), ...
Medical Z, S.A. is engaged in the production of medical devices. more...
Phone: 332-33-73 77
FDA Registration: 8023033
Products: General Surgical Manual Instrument (FDA Code: MDM), Silicone Elastomer (FDA Code: MDA), Skin Pressure Protector (FDA Code: FMP), Therapeutic Medical Binder (FDA Code: MDR), Pelvic Support Band (FDA Code: ISR), Electric Therapeutic Massager (FDA Code: ISA), ...
Medical Z, S.A. is engaged in the production of medical devices. more...
Miracle Medical Industries | Address: 4 Fawzi St, Saraya El Koba Facing, Presidential Palace, Cairo EG-C 11511, Egypt
www.miraclegroup.com.eg | Send Inquiry | Phone: +002-(02)-22834742
FDA Registration: 3006943846 Quality: ISO 9001 -2000 CE mark Certified
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Abdominal Orthosis (FDA Code: KTD), Elastic Stocking (FDA Code: ILG), ...
Miracle Medical Industries specializes in the production of orthopedic rehabilitation products. Our product line comprises of knee, belts, ankle, collar, finger support, arm sling, wrist, clavical sup more...
www.miraclegroup.com.eg | Send Inquiry | Phone: +002-(02)-22834742
FDA Registration: 3006943846 Quality: ISO 9001 -2000 CE mark Certified
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Abdominal Orthosis (FDA Code: KTD), Elastic Stocking (FDA Code: ILG), ...
Miracle Medical Industries specializes in the production of orthopedic rehabilitation products. Our product line comprises of knee, belts, ankle, collar, finger support, arm sling, wrist, clavical sup more...
R82 A/s | Address: Parallelvej 3, Gedved DK-8751, Denmark
www.r82.com | Send Inquiry | Phone: +45-(79)-685888
FDA Registration: 3001657382
Products: Wheelchair Accessories (FDA Code: KNO), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Mechanical Table (FDA Code: INW), Wheelchair Cushions (FDA Code: IMP), Wheelchair Head and Trunk Support (FDA Code: IMS), ...
R82 A/s is a manufacturer of seating, standing and walking aids for disabled children. Our seating systems afford the possible support and mobility. Safe transport is crucial, and a wealth of possible more...
www.r82.com | Send Inquiry | Phone: +45-(79)-685888
FDA Registration: 3001657382
Products: Wheelchair Accessories (FDA Code: KNO), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Mechanical Table (FDA Code: INW), Wheelchair Cushions (FDA Code: IMP), Wheelchair Head and Trunk Support (FDA Code: IMS), ...
R82 A/s is a manufacturer of seating, standing and walking aids for disabled children. Our seating systems afford the possible support and mobility. Safe transport is crucial, and a wealth of possible more...
Ostecare Co., Ltd. | Address: Building No. 2, No.69 Xinyuan South Rd., Xinyang Industry Section, Haicang, Xiamen 361021, China 
Phone: +86-(592)-6513356
FDA Registration: 3007115614
Products: Arm Slings (FDA Code: ILI), Hand Splint and Component (FDA Code: ILH), Corrective Shoe Orthosis (FDA Code: KNP), Overhead Supported Arm Sling (FDA Code: ILE), Temporary Training Splint (FDA Code: IQM), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
Ostecare Co., Ltd. manufactures orthopedic products. Our products include external ankle braces, limb brace orthosis, arm slings, clavicle splint and non-powered traction apparatus. We provide rigid c more...
Phone: +86-(592)-6513356
FDA Registration: 3007115614
Products: Arm Slings (FDA Code: ILI), Hand Splint and Component (FDA Code: ILH), Corrective Shoe Orthosis (FDA Code: KNP), Overhead Supported Arm Sling (FDA Code: ILE), Temporary Training Splint (FDA Code: IQM), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
Ostecare Co., Ltd. manufactures orthopedic products. Our products include external ankle braces, limb brace orthosis, arm slings, clavicle splint and non-powered traction apparatus. We provide rigid c more...
Rehan (Shanghai) Health Care Co., Ltd. | Address: 58,1385 Lane, Jihe Rd., Huaxin Town,, Qingpu Dist. Shanghai, China 201708, Shanghai, CN-31 201708, China
FDA Registration: 3008114969
Products: Elastic Bandages (FDA Code: FQM), Abdominal Binders (FDA Code: FSD), External Non-Inflatable Extremity Splint (FDA Code: FYH), Elastic Binder (FDA Code: KMO), External Ankle Brace (FDA Code: ITW), Pelvic Support Band (FDA Code: ISR), ...
Rehan (Shanghai) Health Care Co., Ltd. specializes in offering orthopedic soft-goods products. We provide back supports, abdominal supports, orthopedic products, knee supports, and shoulder / arm supp more...
FDA Registration: 3008114969
Products: Elastic Bandages (FDA Code: FQM), Abdominal Binders (FDA Code: FSD), External Non-Inflatable Extremity Splint (FDA Code: FYH), Elastic Binder (FDA Code: KMO), External Ankle Brace (FDA Code: ITW), Pelvic Support Band (FDA Code: ISR), ...
Rehan (Shanghai) Health Care Co., Ltd. specializes in offering orthopedic soft-goods products. We provide back supports, abdominal supports, orthopedic products, knee supports, and shoulder / arm supp more...
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FDA Code / Regulation: ISR / 890.3025
A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
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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