External Brace Component Stirrup Suppliers
www.david-medical.com | Phone: +86-(21)-62756686
Products: Oxygen Masks (FDA Code: BYG), Ice Bags (FDA Code: KYR), Manual Stethoscope (FDA Code: LDE), Congenital Hip Dislocation Abduction Splint (FDA Code: IOZ), Hernia Support (FDA Code: EXN), Inflation Bulb For Endoscope (FDA Code: FCY), ...
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.deltai-medical.com | Send Inquiry | Phone: +86-(21)-39527088
FDA Registration: 9616984 Quality: ISO 9001:2000 Certified
Products: Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Bariatric Abdominal Binder, Arm Sling with Foam Strap, Arm Sling Strap Pads, Arm Sling Immobilizer, ...
Deltai Medical is the first orthopedic products manufacturer. Our facilities consist of split, laminating and die cut, orthopedic soft goods plant, orthopedic shoe plant, injection molding plant, meta more...
An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.
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.
