Medical Device Manufacturer · CN , Kunshan

Kunshan Hi-Fortune Health Products Co., Ltd. - FDA 510(k) Cleared Dev...

9 submissions · 9 cleared · Since 2017
9
Total
9
Cleared
0
Denied

Kunshan Hi-Fortune Health Products Co., Ltd. has 9 FDA 510(k) cleared medical devices. Based in Kunshan, CN.

Latest FDA clearance: Mar 2025. Active since 2017. Primary specialty: Physical Medicine.

Browse the FDA 510(k) cleared devices submitted by Kunshan Hi-Fortune Health Products Co., Ltd. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Shanghai SUNGO Management Consulting Co., Ltd. and Shanghai Truthful Information Technology Co., Ltd..

FDA 510(k) Regulatory Record - Kunshan Hi-Fortune Health Products Co., Ltd.
9 devices
1-9 of 9
Cleared Mar 26, 2025
Electrically powered wheelchair
K244003 · ITI
Physical Medicine · 90d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243961 · ITI
Physical Medicine · 51d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243962 · ITI
Physical Medicine · 51d
Cleared Oct 17, 2024
Electrically powered wheelchair (HP202)
K241337 · ITI
Physical Medicine · 157d
Cleared Oct 16, 2024
Electrically powered wheelchair
K241632 · ITI
Physical Medicine · 132d
Cleared Jan 18, 2022
HP458E Electrically Powered Wheelchair
K212503 · ITI
Physical Medicine · 162d
Cleared Jan 04, 2022
HP358EA Electrically Powered Wheelchair
K211647 · ITI
Physical Medicine · 221d
Cleared Sep 28, 2021
Electrically Powered Wheelchair -Model HP358E
K201855 · ITI
Physical Medicine · 449d
Cleared Jul 28, 2017
Wheelchair
K163352 · IOR
Physical Medicine · 240d
Filters
Filter by Specialty
All9 Physical Medicine 9