External Non-Inflatable Extremity Splint Suppliers
Limit companies to: Worldwide USA
I-Ming Sanitary Materials Co.,Ltd. | Address: 101-10 Du Tu Lane., Er Hsi Rd, Peishih Li Hsihu, Chang Hua 514, Taiwan 
www.supports.com.tw | Send Inquiry | Phone: +886-(4)-8819638
FDA Registration: 9616933 Quality: ISO9001, ISO13488 Certified
Products: Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Lumbar Orthosis, Brace (FDA Code: IQE), Compressible Limb Sleeve (FDA Code: JOW), ...
I-Ming Sanitary Materials Co.,Ltd. specializes in designing and manufacturing orthopedics, rehabilitation, health care and sporting supports. Our product range includes health back supports, abdominal more...
www.supports.com.tw | Send Inquiry | Phone: +886-(4)-8819638
FDA Registration: 9616933 Quality: ISO9001, ISO13488 Certified
Products: Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Lumbar Orthosis, Brace (FDA Code: IQE), Compressible Limb Sleeve (FDA Code: JOW), ...
I-Ming Sanitary Materials Co.,Ltd. specializes in designing and manufacturing orthopedics, rehabilitation, health care and sporting supports. Our product range includes health back supports, abdominal 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), Cast Covers (FDA Code: KIA), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), ...
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), Cast Covers (FDA Code: KIA), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), ...
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...
Tricare Medical Co., Ltd. | Address: 11f Dynasty Building, 155, Sec. 1, Keelung Road, Taipei 110, Taiwan
Phone: +886-(2)-27667588
FDA Registration: 3005597721
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Tricare Medical Co., Ltd. deals with medical devices and surgical instruments. We provide arm slings, forceps, ear speculums, injection cannulas, mechanical walker and disposable medical beds. We offe more...
Phone: +886-(2)-27667588
FDA Registration: 3005597721
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Tricare Medical Co., Ltd. deals with medical devices and surgical instruments. We provide arm slings, forceps, ear speculums, injection cannulas, mechanical walker and disposable medical beds. We offe more...
Kao Chen Enterprise Co., Ltd. | Address: No. 68, Lane 326, Sangang Rd., Longjin Village, Longjing, Township, Taichung Co. 434, Taiwan
www.softguards.com | Phone: +866-(4)-26308728
FDA Registration: 3004129296 Year Established: 1979
Products: Elastic Bandages (FDA Code: FQM), Arm Supports (FDA Code: IOY), Lumbar Orthosis, Brace (FDA Code: IQE), External Non-Inflatable Extremity Splint (FDA Code: FYH), Manual Cast Application and Removal Instrument (FDA Code: LGG), Drill Brace (FDA Code: HXY), ...
Kao Chen Enterprise Co., Ltd. manufactures and exports orthopedic supports/splints/protectors, rehabilitation products, health-care products and athletic supports. Our products are cervical collars, c more...
www.softguards.com | Phone: +866-(4)-26308728
FDA Registration: 3004129296 Year Established: 1979
Products: Elastic Bandages (FDA Code: FQM), Arm Supports (FDA Code: IOY), Lumbar Orthosis, Brace (FDA Code: IQE), External Non-Inflatable Extremity Splint (FDA Code: FYH), Manual Cast Application and Removal Instrument (FDA Code: LGG), Drill Brace (FDA Code: HXY), ...
Kao Chen Enterprise Co., Ltd. manufactures and exports orthopedic supports/splints/protectors, rehabilitation products, health-care products and athletic supports. Our products are cervical collars, c more...
Valentine International Limited | Address: 8th Floor, No. 149, Sec. 2, Ta Tung Road, Hsichih, Taipei Hsien 221, Taiwan
www.valentine-dynalife.com | Send Inquiry | Phone: +886-(2)-8692-6662
FDA Registration: 8022890
Products: Tongue Depressors (FDA Code: FMA), Blood pressure Cuffs (FDA Code: DXQ), Adhesive Bandages (FDA Code: KGX), Wheelchair Accessories (FDA Code: KNO), Cast Covers (FDA Code: KIA), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), ...
Valentine International Limited specializes in the development of medical products. Our products include wheelchairs, bathroom safety aids, mobility, rehabilitation, orthopedic products, furniture & e more...
www.valentine-dynalife.com | Send Inquiry | Phone: +886-(2)-8692-6662
FDA Registration: 8022890
Products: Tongue Depressors (FDA Code: FMA), Blood pressure Cuffs (FDA Code: DXQ), Adhesive Bandages (FDA Code: KGX), Wheelchair Accessories (FDA Code: KNO), Cast Covers (FDA Code: KIA), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), ...
Valentine International Limited specializes in the development of medical products. Our products include wheelchairs, bathroom safety aids, mobility, rehabilitation, orthopedic products, furniture & e more...
Centri AB | Address: Box 760, Sollentuna 191 27, Sweden
www.centri.se | Send Inquiry | Phone: +46-(8)-505-33-200
FDA Registration: 9681133 Year Established: 1948
Products: External Non-Inflatable Extremity Splint (FDA Code: FYH), ...
Centri AB manufactures, develops and distributes orthopedic technical devices in four segments such as upper extremity components, lower extremity components, orthotics & shoes. Dynamic Walk is our or more...
www.centri.se | Send Inquiry | Phone: +46-(8)-505-33-200
FDA Registration: 9681133 Year Established: 1948
Products: External Non-Inflatable Extremity Splint (FDA Code: FYH), ...
Centri AB manufactures, develops and distributes orthopedic technical devices in four segments such as upper extremity components, lower extremity components, orthotics & shoes. Dynamic Walk is our or more...
Plasco, Inc. | Address: Carretera Presta La Amistad, Km.19, Acuna, Coahila, Mexico
Phone: +52-(847)-662-4400
FDA Registration: 9616564
Products: Urine Collection Leg Bags (FDA Code: FAQ), Surgical Drapes & Packs (FDA Code: KKX), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Surgical Drapes (FDA Code: KKX), Urological Catheters (FDA Code: KOD), ...
Plasco, Inc. is a provider of disposable surgical drapes, elastic bandages, manual vacuum-assisted blood collect systems, thermal regulating systems and urology surgical drapes. more...
Phone: +52-(847)-662-4400
FDA Registration: 9616564
Products: Urine Collection Leg Bags (FDA Code: FAQ), Surgical Drapes & Packs (FDA Code: KKX), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Surgical Drapes (FDA Code: KKX), Urological Catheters (FDA Code: KOD), ...
Plasco, Inc. is a provider of disposable surgical drapes, elastic bandages, manual vacuum-assisted blood collect systems, thermal regulating systems and urology surgical drapes. more...
Smith & Nephew S.A. de C.V. | Address: Patricio Sanz 442, Col. del Valle, Deleg. Benito Juárez D.F. 03100, Mexico
global.smith-nephew.com/master | Send Inquiry | Phone: +52-(5340)-2260
FDA Registration: 9612388
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Hydrophilic Wound Dressings (FDA Code: NAC), Lumbar Orthosis, Brace (FDA Code: IQE), ...
Smith & Nephew S.A. de C.V. provides arthroscopy blades, antimicrobial dressing and resurfacing system. We are specialized in orthopedic reconstruction & trauma, endoscopy, clinical therapies and adva more...
global.smith-nephew.com/master | Send Inquiry | Phone: +52-(5340)-2260
FDA Registration: 9612388
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Hydrophilic Wound Dressings (FDA Code: NAC), Lumbar Orthosis, Brace (FDA Code: IQE), ...
Smith & Nephew S.A. de C.V. provides arthroscopy blades, antimicrobial dressing and resurfacing system. We are specialized in orthopedic reconstruction & trauma, endoscopy, clinical therapies and adva more...
DJ Orthopedics De Mexico, S.A. De C.V. | Address: Blvd., Delagacion La Presa, Otay Insurgentes 16695-1, Tijuana 22397, Mexico
Phone: +52-(664)-627-1300
FDA Registration: 9616086
Products: Catheter Accessories (FDA Code: KGZ), Cervicothoracic Lumbar Orthosis, Wheelchair Accessories (FDA Code: KNO), Arm Support Extender:, Wheelchair Accessories, Carrying Accessories, Wheelchair Accessories, Battery Charger, ...
DJ Orthopedics De Mexico, S.A. De C.V. offers orthopedic, prosthetic and surgical appliances & supplies. Our products include abdominal binders, ankle braces, abdominal supports, athletic tapes, cathe more...
Phone: +52-(664)-627-1300
FDA Registration: 9616086
Products: Catheter Accessories (FDA Code: KGZ), Cervicothoracic Lumbar Orthosis, Wheelchair Accessories (FDA Code: KNO), Arm Support Extender:, Wheelchair Accessories, Carrying Accessories, Wheelchair Accessories, Battery Charger, ...
DJ Orthopedics De Mexico, S.A. De C.V. offers orthopedic, prosthetic and surgical appliances & supplies. Our products include abdominal binders, ankle braces, abdominal supports, athletic tapes, cathe more...
Join Enterprise, Ltd. | Address: 619-8 Tongsam-Ri, Namsa-Myeon, Cheoin-Gu, Yongin-City, Gyeonggi-Province, Korea, Republic Of 
Phone: +82-(614)-7349823
FDA Registration: 3004179819
Products: Fiberglass Cast Boot, Fiberglass Casting Material, Bandages, Splints, Spoon, Cast & Bandage Protectors, Fiberglass Cast Tapes, ...
Join Enterprise, Ltd. focuses on bandages and splints. Our products include fiberglass & polyester based casting tapes and non inflatable extremity splints. We provide cast bandage and non-sterile ext more...
Phone: +82-(614)-7349823
FDA Registration: 3004179819
Products: Fiberglass Cast Boot, Fiberglass Casting Material, Bandages, Splints, Spoon, Cast & Bandage Protectors, Fiberglass Cast Tapes, ...
Join Enterprise, Ltd. focuses on bandages and splints. Our products include fiberglass & polyester based casting tapes and non inflatable extremity splints. We provide cast bandage and non-sterile ext more...
General Surgical Co., (india) Pvt. Ltd. | Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India 
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic 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, Industrial Back Support, Maternity Supports, Adjustable Knee Brace, Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), ...
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, Industrial Back Support, Maternity Supports, Adjustable Knee Brace, Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), ...
Allmay International Limited provides orthopedic products to customers. Our products include cervical collar, neoprene shoulder support, adjustable rigid collar, clavicle brace, shoulder immobilizer, more...
Waldemar Link GmbH & Co. KG | Address: Barkhausenweg 10, Hamburg D-22339, Germany 
www.waldemarlink.com | Send Inquiry | Phone: +49-(40)-539950
FDA Registration: 3004371426
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Electrode Cables (FDA Code: IKD), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), ...
Waldemar Link GmbH & Co. KG specializes in supplying hospital products. We also manufacture orthopedic implants and surgical instruments. Our implants are manufactured under high-tech conditions. Our more...
www.waldemarlink.com | Send Inquiry | Phone: +49-(40)-539950
FDA Registration: 3004371426
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Electrode Cables (FDA Code: IKD), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), ...
Waldemar Link GmbH & Co. KG specializes in supplying hospital products. We also manufacture orthopedic implants and surgical instruments. Our implants are manufactured under high-tech conditions. Our more...
Hans Stollenwerk Cie Gmbh & Co. | Address: Dellbruecker Hauptstr. 197-201, Koeln 51069, Germany
Phone: +49-(221)-686-020
Employee Count: ~60
Products: Transfer Stretcher, Leg Supports, Adjustable Leg Support Stand, Surgical Tables Accessories, Self Adjusting Leg Supports, Leg Support Stocking, External Non-Inflatable Extremity Splint (FDA Code: FYH), ...
Hans Stollenwerk Cie Gmbh & Co. specializes in the production of stretchers and vehicles for stretchers. We also offer various other products including first aid kits, ambulance closets, first aid cab more...
Phone: +49-(221)-686-020
Employee Count: ~60
Products: Transfer Stretcher, Leg Supports, Adjustable Leg Support Stand, Surgical Tables Accessories, Self Adjusting Leg Supports, Leg Support Stocking, External Non-Inflatable Extremity Splint (FDA Code: FYH), ...
Hans Stollenwerk Cie Gmbh & Co. specializes in the production of stretchers and vehicles for stretchers. We also offer various other products including first aid kits, ambulance closets, first aid cab more...
Koch Kg, P. | Address: Paulusstr 14, Neuffen 72639, Germany
Phone: +49-(7025)-910-020
Employee Count: ~50
Products: Patient Lifters (FDA Code: FNG), Finger Protector Splint, Transfer Patient Lifts, Hydraulic Patient Lifter, Rehabilitation Equipment, Patient Lifts And Slings, 3-Panel Knee Immobilizer, ...
Koch Kg, P. specializes in offering extension bandages and accessories. We offer electronic rehabilitation machine for the passive exercise of the lower limbs with integrated power supply unit. more...
Phone: +49-(7025)-910-020
Employee Count: ~50
Products: Patient Lifters (FDA Code: FNG), Finger Protector Splint, Transfer Patient Lifts, Hydraulic Patient Lifter, Rehabilitation Equipment, Patient Lifts And Slings, 3-Panel Knee Immobilizer, ...
Koch Kg, P. specializes in offering extension bandages and accessories. We offer electronic rehabilitation machine for the passive exercise of the lower limbs with integrated power supply unit. more...
Guangzhou Fortunique Ltd. | Address: Block B 2, Zhou Shan Gang, Shi Bei Industrial Ave, Pan Yu Dist., Guangzhou 511410, China 
FDA Registration: 3003915904
Products: Patient Examination Gowns and Capes (FDA Code: FME), Arm Slings (FDA Code: ILI), Ice Bags (FDA Code: KYR), Bone Clamp (FDA Code: HXD), Traction Accessories, Leg Straps (FDA Code: ILZ), Examination Gown (FDA Code: FME), ...
Guangzhou Fortunique Ltd. is a contract manufacturer of surgical and medical products. Our product line consists of arm slings, corrective shoe orthosis, disposable medical beds, surgical cameras, han more...
FDA Registration: 3003915904
Products: Patient Examination Gowns and Capes (FDA Code: FME), Arm Slings (FDA Code: ILI), Ice Bags (FDA Code: KYR), Bone Clamp (FDA Code: HXD), Traction Accessories, Leg Straps (FDA Code: ILZ), Examination Gown (FDA Code: FME), ...
Guangzhou Fortunique Ltd. is a contract manufacturer of surgical and medical products. Our product line consists of arm slings, corrective shoe orthosis, disposable medical beds, surgical cameras, han more...
Shanghai Sumiec Imp. & Exp. Corporation | Address: 5 Fl., Zhuhui Commercial Bldg., 180 Zhuhui Rd., Suzhou, Jiangsu Province 215006, China
Phone: 847-6820224
FDA Registration: 3001650535
Products: Ice Bags (FDA Code: KYR), Latex Finger Cots (FDA Code: LZB), Sterile Arm Board with Cover (FDA Code: BTX), Finger Cot (FDA Code: LZB), Y Piece Breathing Circuit (FDA Code: CAI), Disposable Suture Needle (FDA Code: GAB), ...
Shanghai Sumiec Imp. & Exp. Corporation is a manufacturer of various surgical and medical equipments. We offer battery-powered medical examination lights, ophthalmic eye shields, bed patient monitors, more...
Phone: 847-6820224
FDA Registration: 3001650535
Products: Ice Bags (FDA Code: KYR), Latex Finger Cots (FDA Code: LZB), Sterile Arm Board with Cover (FDA Code: BTX), Finger Cot (FDA Code: LZB), Y Piece Breathing Circuit (FDA Code: CAI), Disposable Suture Needle (FDA Code: GAB), ...
Shanghai Sumiec Imp. & Exp. Corporation is a manufacturer of various surgical and medical equipments. We offer battery-powered medical examination lights, ophthalmic eye shields, bed patient monitors, more...
David Medical Products (Suzhou) Co., Ltd. | Address: No.88, Fuda Road, Ludu Town, Taicang, Suzhou, Taicang 215400, China
www.david-medical.com | Phone: +86-(21)-62756686
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Pneumatic Tourniquet (FDA Code: KCY), ...
David Medical Products (Suzhou) Co., Ltd. is engaged in the production of EMS and first aid products. Our EMS products include resuscitator, mouth opener, airway, CPR shield, mask, rescue board and sy more...
www.david-medical.com | Phone: +86-(21)-62756686
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Pneumatic Tourniquet (FDA Code: KCY), ...
David Medical Products (Suzhou) Co., Ltd. is engaged in the production of EMS and first aid products. Our EMS products include resuscitator, mouth opener, airway, CPR shield, mask, rescue board and sy more...
Wenzhou Wuzhou Group Co., Ltd. | Address: Rm. 606-608 Dongfang Bldg., Wenzhou, China
www.wetd.com | Send Inquiry | Phone: +86-(577)-88868062
FDA Registration: 9681901 Quality: CE Certified
Products: Blood pressure Cuffs (FDA Code: DXQ), Piston Syringe (FDA Code: FMF), Manual Stethoscope (FDA Code: LDE), Blood Collection Systems (FDA Code: JKA), Disposable Aspiration and Injection Needle (FDA Code: GAA), External Non-Inflatable Extremity Splint (FDA Code: FYH), ...
Wenzhou Wuzhou Group Co., Ltd. manufactures disposable medical items and a series of sphygmomanometers. Our product list comprises of disposable syringes, disposable needles, scalp vein sets, irrigati more...
www.wetd.com | Send Inquiry | Phone: +86-(577)-88868062
FDA Registration: 9681901 Quality: CE Certified
Products: Blood pressure Cuffs (FDA Code: DXQ), Piston Syringe (FDA Code: FMF), Manual Stethoscope (FDA Code: LDE), Blood Collection Systems (FDA Code: JKA), Disposable Aspiration and Injection Needle (FDA Code: GAA), External Non-Inflatable Extremity Splint (FDA Code: FYH), ...
Wenzhou Wuzhou Group Co., Ltd. manufactures disposable medical items and a series of sphygmomanometers. Our product list comprises of disposable syringes, disposable needles, scalp vein sets, irrigati 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), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Lumbar Orthosis, Brace (FDA Code: IQE), External Non-Inflatable Extremity Splint (FDA Code: FYH), ...
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), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Lumbar Orthosis, Brace (FDA Code: IQE), External Non-Inflatable Extremity Splint (FDA Code: FYH), ...
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: FYH / 878.3910
A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.
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 878.9. If the device is not labeled or otherwise represented as sterile, it is 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 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.
