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510(k) Data Aggregation
K Number
K033125Device Name
HANDIVIPP
Manufacturer
Date Cleared
2003-10-30
(30 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
HANDINOR USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HandiNor HandiVipp is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Handivipp is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
The HandiNor HandiVipp is indicated for individuals with postural challenges e.g. Individuals with Scoliosis, Kyphosis, Cerebral Palsy, Muscular Dystrophy, Multiple Sclerosis, CVA, Spinal Chord injury, Spina Bifida, ALS and similar Neuromuscular and Musculoskeletal pathologies.
Device Description
The HandiVipp comfort wheelchair, "HandiVipp", is a manually operated, self propelled or attendant propelled mechanical wheelchair. The HandiVipp 's intended use is to provide mobility to persons who may require specialized postural support and tilting features to assist in feeding and pressure relief. It is designed to meet the mobility and positioning needs of individuals with postural challenges e.g. Individuals with Scoliosis, Kyphosis. Cerebral Palsy. Muscular Dystrophy, Multiple Sclerosis and the like.
The HandiVipp frame is constructed from both 22 mm and 18 mm outside diameter (OD) round, mechanical, steel tubing. The side frames are of welded construction and are secured to the remaining frame members using screws and bolts. This device is a rigid wheelchair that incorporates a solid seating surface. The back frame can be folded by releasing a bolt. The seating plate (plain seat) has different hooks and different height levels on the hooks (short (standard), long and plain). This type of seat makes the chair easily adaptable to the various types of wheelchair cushions and seating systems.
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