Electrically powered wheelchair— 510(k) K244003

Clearance details

Applicant

Kunshan Hi-Fortune Health Products Co., Ltd.

Product code

Code ITI

Device class

Class 2

Regulation

21 CFR 890.3860

Advisory panel

Physical Medicine

Date received

2024-12-26

Decision date

2025-03-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kunshan, CN

• K260053 — Power Wheelchair (OS-R-M01I)2026-09-08
• K260229 — Electric wheelchair (HC819N, HC830N, HC831N)2026-09-08
• K261354 — Electric wheelchair (D03)2026-08-21
• K261149 — Electric Wheelchair (DY611A-2, DY612A-1)2026-07-10
• K261396 — Electric Wheelchair2026-07-08

• K243961 — Electrically Powered Wheelchair2025-02-12
• K243962 — Electrically Powered Wheelchair2025-02-12
• K241337 — Electrically powered wheelchair (HP202)2024-10-17
• K241632 — Electrically powered wheelchair2024-10-16
• K212503 — HP458E Electrically Powered Wheelchair2022-01-18

Death

34

Injury

778

Malfunction

1,085

Other

1

Total

1,898

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →