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Address: 60 Feihu Rd., Ludu, Taicang, Suzhou, Jiangsu 215412, China
www.deltai-medical.com |
Send Inquiry |
Phone: +86-(21)-39527088
FDA Registration: 9616984 Quality: ISO 9001:2000 Certified
Products: Arm Slings (FDA Code:
ILI), Bed Transfer Aids, Ice Bags (FDA Code:
KYR), Arm Supports (FDA Code:
IOY), Disposable Arm Slings, Envelope Arm Sling, ...
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
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Address: 2465, Las Dalias, Macul Santiago, Chile
www.blunding.com |
Phone: +56-(2)-237-3121
FDA Registration: 3006755899 Quality: ISO 9001:2000 Certified
Products: Adhesive Bandages (FDA Code:
KGX), Elastic Bandages (FDA Code:
FQM), Foley Catheter Holders (FDA Code:
EYJ), Arm Slings (FDA Code:
ILI), Arm Supports (FDA Code:
IOY), Cervical Thoracic Orthosis (FDA Code:
IPT), ...
Blunding S.A. specializes in providing clinical strips, orthopedic and plastic surgery products. Our cervical collar firm density is a stable open-pore foam used for the operations of tilted neck and
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Address: 7109, Trans-Canada, Montréal, Quebec H4T 1A2, Canada
www.formedica.com |
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Phone: +1-(514)-336-4821, 800-361-9671
Year Established: 1972
Annual Revenues: USD 5-10 Million
Employee Count: ~60
Quality: CE Certified
Products: Splints, Occupational Back Support, Ergonomic Wrist Support, Arm Support Extender:, Toilet Aids, Toilet Safety Arm Support, Shiatsu Back Support, ...
Formedica Ltd. specializes in orthopedic products. Our products include thermo frame, sacro forme, ergo sport, ergo select, posture plus, and surgi forme. Our first aid products include thermo therape
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Address: Pelican's Nest' 7 Ruse Street, Osborne Park, Western Australia 6018, Australia
www.pelicanmanufacturing.com.au |
Send Inquiry |
Phone: +61-(89444)-4577,800-641-577
FDA Registration: 3003591851 Year Established: 1987
Products: Wheelchair Accessories (FDA Code:
KNO), Arm Supports (FDA Code:
IOY), Lumbar Orthosis, Brace (FDA Code:
IQE), Transfer Aid for Disabled/Handicapped (FDA Code:
IKX), Transfer Aid (FDA Code:
IKX), Non AC-Powered Patient Lift (FDA Code:
FSA), ...
Pelican Mfg. Pty. Ltd. provides selected pressure care items for geriatric patients in nursing homes and hospitals. Our product area includes pressure care items, patient dignity & care, physiotherapy
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FDA Code / Regulation: IOY / 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.