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Address: 107 Merner Ave., Kitchener, Ontario N2H 1X5, Canada
www.alignright.com |
Send Inquiry |
Phone: (519)-742-9873, 800-331-0907
Products: Abdominal Orthosis (FDA Code:
KTD), ...
The Align-Right Pillow Co. Ltd. is a provider of sleeping pillows. Our pillow products help reduce back and neck pain. Our pillows reduce the problems such as neck strain/stress, headaches, migraines,
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Address: 189 Colonnade Rd., South, Nepean, Ontario K2E 7J4, Canada
www.airwaysurgical.ca |
Send Inquiry |
Phone: +1-(800)-267-3476
FDA Registration: 9611956
Products: Elastic Bandages (FDA Code:
FQM), Arm Slings (FDA Code:
ILI), Cervical Thoracic Orthosis (FDA Code:
IPT), Cervical Orthosis (FDA Code:
IQK), Clavicle Splint (FDA Code:
IQJ), Congenital Hip Dislocation Abduction Splint (FDA Code:
IOZ), ...
Airway Surgical Appliances Ltd. manufactures health care products. Our products include compression hosieries, supports, splints, braces, home medical supplies & equipments, airway mastectomy products
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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: KTD / 890.3490 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.