# K243962: Electrically Powered Wheelchair

- Pathway: 510(k) (Special)
- Applicant: Kunshan Hi-Fortune Health Products Co., Ltd.
- Decided: Feb 12, 2025 after 51 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K170787 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212503: HP458E Electrically Powered Wheelchair, Kunshan Hi-Fortune Health Products Co., Ltd. (2022) Summary page 6.

## Indications for use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Source page: https://510kreport.com/device/K243962
Methodology: https://510kreport.com/methodology