# K033125: Handivipp

- Pathway: 510(k) (Traditional)
- Applicant: Handinor USA, Inc.
- Decided: Oct 30, 2003 after 30 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952641 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952641: Quickie TSR, Sunrise Medical, Inc. (1995) Summary page 1.

## Indications for 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 Neuromuscularand Musculoskeletal pathologies.

Source page: https://510kreport.com/device/K033125
Methodology: https://510kreport.com/methodology