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Address: No. 68, Lane 326, Sangang Rd., Longjin Village, Longjing, Township, Taichung Co. 434, Taiwan
www.softguards.com |
Phone: +866-(4)-26308728
FDA Registration: 3004129296 Year Established: 1979
Products: Elastic Bandages (FDA Code:
FQM), Lumbar Orthosis, Brace (FDA Code:
IQE), External Non-Inflatable Extremity Splint (FDA Code:
FYH), Hand Splint and Component (FDA Code:
ILH), External Ankle Brace (FDA Code:
ITW), External Brace Knee Joint (FDA Code:
ITQ), ...
Kao Chen Enterprise Co., Ltd. manufactures and exports orthopedic supports/splints/protectors, rehabilitation products, health-care products and athletic supports. Our products are cervical collars, c
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Address: Parallelvej 3, Gedved DK-8751, Denmark
www.r82.com |
Send Inquiry |
Phone: +45-(79)-685888
FDA Registration: 3001657382
Products: Wheelchair Accessories (FDA Code:
KNO), Disabled/Handicapped Manual Wheelchair (FDA Code:
IOR), Mechanical Wheelchair (FDA Code:
IOR), Mechanical Table (FDA Code:
INW), Wheelchair Cushions (FDA Code:
IMP), Wheelchair Head and Trunk Support (FDA Code:
IMS), ...
R82 A/s is a manufacturer of seating, standing and walking aids for disabled children. Our seating systems afford the possible support and mobility. Safe transport is crucial, and a wealth of possible
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Address: 125 Knott Place, Salt Spring Island, British Columbia V8K 2M4, Canada
www.symmetric-designs.com |
Send Inquiry |
Phone: +1-(250)-537-2177/800-537-1724
FDA Registration: 9680670 Year Established: 1986
Annual Revenues: < USD 1 Million
Employee Count: ~10
Products: User-Friendly Wheelchairs, Manual Wheelchairs, Wheelchair Accessories, Anti Fold Device, Wheelchair Accessories, Amputee Axle Kit, Wheelchair Accessories, Anti-Fold/Anti-Theft Device, Wheelchair Accessories, Amputee Axle Plate, ...
Symmetric Designs is a creater and manufacturer of medical products. We supply Headmaster Cervical Collar™, The TOT Collar™, knee & elbow orthosis, wheelchair tray & accessories, medical w
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Address: Unit # 5 - 16 Mazenod Road, Winnipeg, Manitoba R2J 4H2, Canada
www.daherproducts.com |
Send Inquiry |
Phone: +1-(204)-663-3299
FDA Registration: 9615404
Products: Wheelchair Armboard (FDA Code:
IMY), Wheelchair Belt (FDA Code:
IQB), Wheelchair Head and Trunk Support (FDA Code:
IMS), ...
Daher Mfg., Inc. is specialized in custom foam molding products. We produce products that are specifically designed to assist the non-ambulatory handicapped populations. Our flexible products are made
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Address: 385 Phillip Street, Waterloo, Ontario N2L 5R8, Canada
www.brodaseating.com |
Send Inquiry |
Phone: +1-(519)-746-8080
FDA Registration: 8043392 Year Established: 1981
Annual Revenues: USD 5-10 Million
Employee Count: ~50
Quality: CE Certified
Products: Wheelchairs, Manual Wheelchairs, Wheelchairs/accessories, Bariatric Equipment, Disabled/Handicapped Manual Wheelchair (FDA Code:
IOR), Mechanical Wheelchair (FDA Code:
IOR), ...
Broda Seating manufactures tilt and recline positioning chairs for long term care. We supply auto locking glider chair, elite accessories, pedal chair and tilt wheelchair & shower commode chair. Our a
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FDA Code / Regulation: IMS / 890.3910 A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.
Classification. Class I (general controls). If the device is not intended for use as a protective restraint as defined in 880.6760 of this chapter, it 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.