# Kunshan Hi-Fortune Health Products Co., Ltd.

- Location (FDA's records): Kunshan, CN
- FDA decisions: 9 (2017–2025): 9 510(k) clearances
- Product codes: ITI (8), IOR (1)
- 510(k) review time since 2016: median 157 days, against 96 for FDA's reviews in the same codes and years (2 of 9 faster)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nanjing Jin Bai HE Medical Apparatus Co., Ltd.: 2 (https://510kreport.com/company/nanjing-jin-bai-he-medical-apparatus)
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd: 2 (https://510kreport.com/company/zhejiang-innuovo-rehabilitation-devices)
- Forcemech International, LLC: 1 (https://510kreport.com/company/forcemech-international)
- Danyang Sunco Machinery Co., Ltd.: 1 (https://510kreport.com/company/danyang-sunco-machinery)

## Firms that cite its devices most
- Zhenjiang Assure Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/zhenjiang-assure-medical-equipment)
- Jiangyin Newrise Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/jiangyin-newrise-medical-equipment)

## Its most-cited devices
- K211647: HP358EA Electrically Powered Wheelchair (2022), cited by 1
- K244003: Electrically powered wheelchair (2025), cited by 1
- K212503: HP458E Electrically Powered Wheelchair (2022), cited by 1
- K163352: Wheelchair (2017), cited by 1

## Recent decisions
- K244003: Electrically powered wheelchair (Mar 26, 2025)
- K243961: Electrically Powered Wheelchair (Feb 12, 2025)
- K243962: Electrically Powered Wheelchair (Feb 12, 2025)
- K241337: Electrically powered wheelchair (HP202) (Oct 17, 2024)
- K241632: Electrically powered wheelchair (Oct 16, 2024)
- K212503: HP458E Electrically Powered Wheelchair (Jan 18, 2022)
- K211647: HP358EA Electrically Powered Wheelchair (Jan 4, 2022)
- K201855: Electrically Powered Wheelchair -Model HP358E (Sep 28, 2021)

Source page: https://510kreport.com/company/kunshan-hi-fortune-health-products