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Address: Manhattan Special Economic Zone, National Rd. #1, Bavet Commune, Chantrea District, KH-20 0, Cambodia
Products: Elastic Binder (FDA Code:
KMO), External Brace Knee Joint (FDA Code:
ITQ), Limb Brace Orthosis (FDA Code:
IQI), ...
Sheico Cambodia Co., Ltd. specializes in limb brace orthosis and elastic binders.
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Address: 93, Islampur, P.U. Kadda, Gazipur GA 21 PUR, Bangladesh
Phone: +880-(805)-688-9718
FDA Registration: 3006619688
Products: Arm Slings (FDA Code:
ILI), Cast Shoe (FDA Code:
IPG), Knee Support, Hand Splint and Component (FDA Code:
ILH), External Ankle Brace (FDA Code:
ITW), External Brace Knee Joint (FDA Code:
ITQ), ...
United Surgical, Ltd. deals with ankle supports, arm slings, cast shoes, knee supports, lumbo-sacral orthosis and wrist braces.
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Address: Office 4, 110 Surfcoast Hwy, Torquay, AU-VI 3228, Australia
FDA Registration: 3007120605
Products: External Brace Knee Joint (FDA Code:
ITQ), ...
Pod Orthotic Pty., Ltd. specializes in external brace knee joints.
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Address: 10 Eastspur Ct., Kilsyth, Victoria 3137, Australia
www.unitedpac.com.au |
Send Inquiry |
Phone: +61-(3)-97617599, 800 188 019 (
FDA Registration: 8043954 Quality: ISO9002 Certified
Products: Elastic Binder (FDA Code:
KMO), Cutaneous Electrode (FDA Code:
GXY), External Brace Knee Joint (FDA Code:
ITQ), Limb Brace Orthosis (FDA Code:
IQI), ...
United Pacific Industries Pty. Ltd (UPI) is a manufacturer and distributor of clinically proven, high quality healthcare bands. Our products range include thermoskin, swede-o, sea-band and others. The
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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,
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FDA Code / Regulation: ITQ / 890.3475 A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
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.