Lumbosacral Orthosis Suppliers
www.pantymed.com | Send Inquiry | Phone: +54-(11)-45 81 87 48
FDA Registration: 3003829642 Quality: ISO 9001, CE Mark Certified
Products: Cast Shoe (FDA Code: IPG), Abdominal Orthosis (FDA Code: KTD), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), Limb Brace Orthosis (FDA Code: IQI), Reusable Hot /Cold Pack (FDA Code: IME), ...
Pantymed S.A. offers higher limb, lower limb & neck/trunk products and elastic bandages. Our higher limb products include wrist, hand, elbow and arm bands. Our neck/trunk products include neck belts, more...
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.
