Reusable Hot /Cold Pack Suppliers
Pantymed S.A. | Address: Fragata Sarmiento 1569, Buenos Aires 1416CBI, Argentina
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...
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...
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FDA Code / Regulation: IME / 890.5700
A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
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