# K211647: HP358EA Electrically Powered Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Kunshan Hi-Fortune Health Products Co., Ltd.
- Decided: Jan 4, 2022 after 221 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K243961: Electrically Powered Wheelchair (2025), 0 descendants of its own

## Indications for use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Source page: https://510kreport.com/device/K211647
Methodology: https://510kreport.com/methodology