# K032101: Powerstand Stand-UP Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: The Standing Co., Inc.
- Decided: Jan 22, 2004 after 198 days
- Product code: IPL (Wheelchair, Standup)
- Device class: 2
- Regulation: 21 CFR 890.3900
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- May 16, 13 · Class II · Z-0993-2014: Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexs

## Indications for use
The Powerstand Standing Wheelchair in indicated, BY PRESCRIPTION ONLY, for users who have had, or may have in the future, positioning disorders relating to paralysis, paresis or general weakness. The Powerstand Standing Wheelchair helps users with mobility.

Source page: https://510kreport.com/device/K032101
Methodology: https://510kreport.com/methodology