Medical Device Manufacturer · CN , Kunshan

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

9 submissions · 9 cleared · Since 2017

Recent clearances: Electrically powered wheelchair, Electrically Powered Wheelchair, Electrically Powered Wheelchair

9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Kunshan Hi-Fortune Health Products Co., Ltd. Physical Medicine ✕

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
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