# K980107: Runch Industrial Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Runch Group USA, Inc.
- Decided: Feb 19, 1998 after 38 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A mechanical, manual, foldable wheelchair which can be used in a residential environment, managed caré or public facility. This device is for incapacitated and partially incapacitated persons requiring mobility in a sitting position.” The device can be operated by using downward (forward) strokes or upward (backward) strokes by the operator on the hand rim steering device attached to an made part of the wheel. To turn left or right, apply pressure on the hand rim. The device can also be powered by an attendant pushing the device with the two (left and right) rear handles. Brakes are located on either side of each wheel and can operated by the left or right hand. Expendable energy is minimal and efficient when traveling short distances.

Source page: https://510kreport.com/device/K980107
Methodology: https://510kreport.com/methodology