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Address: 9241 Lazy Ln., Tampa, Florida 33614, USA
www.clinicaremed.com |
Send Inquiry |
Phone: +1-(800)-603-3737
FDA Registration: 1064732
Products: Therapeutic Healing Shoe, Ankle Foot Orthosis, Abdominal Orthosis (FDA Code:
KTD), Hand Splint and Component (FDA Code:
ILH), Limb Brace Orthosis (FDA Code:
IQI), Foot Drop Orthosis (FDA Code:
OHI), ...
Clinicare Medical Resources, Inc. is a provider of medical equipment and services for home health care and for patients who need long term care. We specialize in the area of geriatric contracture and
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Address: 81 Pondfield Road #157, Bronxville, New York 10708-0850, USA
www.x-strap.com |
Send Inquiry |
Phone: +1-(914)-968-3381
FDA Registration: 2435901 Year Established: 1987
Annual Revenues: < USD 1 Million
Products: Shin Splints, Achilles Tendon Support Brace, Limb Brace Orthosis (FDA Code:
IQI), Foot Drop Orthosis (FDA Code:
OHI), Foot Splints, ...
X-Strap Systems provides solutions for foot drop, shin splints, heel spurs and sprained ankles. The Sprain-Guard™ is used successfully in rehab applications with patients receiving treatment for
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Address: 2710 Amnicola Hwy., Chattanooga, Tennessee 37406-0189, USA
www.fillauer.com |
Send Inquiry |
Phone: +1-(423)-624-0946, 800-251-6398
FDA Registration: 1022826 Year Established: 1914
Annual Revenues: USD 10-25 Million
Employee Count: ~110
Quality: ISO 9001, CE Certified
Products: Cervicothoracic Lumbar Orthosis, Arm Prosthesis, Cervical Thoracic Orthosis (FDA Code:
IPT), Congenital Hip Dislocation Abduction Splint (FDA Code:
IOZ), Denis Brown Splint (FDA Code:
ITN), Foot Drop Orthosis (FDA Code:
OHI), ...
Fillauer Companies, Inc. is a manufacturer of orthotic and prosthetic products. Our swing phase lock is mounted on the lateral side. In this, the control joint uses friction to regulate knee flexion w
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Address: 4 Ford Road, Peasedown St John, Bath BA2 8DG, United Kingdom
www.musmate.co.uk |
Send Inquiry |
Phone: +44-((0845))-094 4674
Products: Walking Aids, Leg and Ankle Exerciser, Non-Measuring Exerciser (FDA Code:
ION), Foot Drop Orthosis (FDA Code:
OHI), ...
Musmate Ltd develops a range of walking aid products. Our Musmate walking aid is intended to assist people with foot drop. This product consists of a shoulder harness which is connected to the foot wi
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Address: 26 Dakota Crescent, Christchurch, Canterbury 8042, New Zealand
www.formthotics.co.nz |
Phone: +64-((0)3)-348-2115
FDA Registration: 3006158810
Products: Ankle Foot Orthosis, Dorsal Ankle Foot Orthosis, Limb Brace Orthosis (FDA Code:
IQI), Foot Drop Orthosis (FDA Code:
OHI), ...
Foot Science International, Ltd. manufactures and markets Formthotics™ brand foot orthotics. Our Formthotic insole is used to correct posture, control excess pronation, provide good arch support
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Address: 4-3995 Sladeview Crescent, Mississauga, Ontario L5L 5Y1, Canada
www.aodmobility.com |
Send Inquiry |
Phone: +1-(905)-607-4022
Products: Insoles & Footwear, Semi-rigid Orthotics, Orthotics, Raw Materials, Footwear, Women, Ankle Foot Orthosis, Mechanical Walker (FDA Code:
ITJ), ...
Advanced Orthotic Designs Inc. specializes in the design, fabrication and fitting of complex orthopedic devices for persons with physical disabilities. We offer mobility devices and walkers, pediatric
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FDA Code / Regulation: OHI / 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.