Hong Qiangxing (Shenzhen) Electronics Limited is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Hong Qiangxing (Shenzhen) Electronics Limited - FDA 510(k) Cleared De...
Recent clearances: TENS&EMS (HZ9151B, HZ9151C, HZ9151D), TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033), TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
9
Total
9
Cleared
0
Denied
Hong Qiangxing (Shenzhen) Electronics Limited has 9 FDA 510(k) cleared medical devices. Based in Shanghai, CN.
Latest FDA clearance: Dec 2025. Active since 2013. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Hong Qiangxing (Shenzhen) Electronics Limited Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Shanghai CV Technology Co., Ltd. and Regulatory Technology Services, LLC.
FDA 510(k) Regulatory Record - Hong Qiangxing (Shenzhen) Electronics Limited
9 devices
Cleared
Dec 23, 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
Neurology
29d
Cleared
May 02, 2022
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
Neurology
90d
Cleared
Apr 19, 2022
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
Neurology
90d
Cleared
Feb 17, 2022
TENS & PMS (Model: SM9126)
Neurology
29d
Cleared
Dec 11, 2020
TENS & PMS
Physical Medicine
204d
Cleared
Dec 02, 2019
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
Neurology
333d
Cleared
Mar 26, 2019
SM Electrodes
Neurology
132d
Cleared
Aug 05, 2014
FIT BELT
Physical Medicine
309d
Cleared
May 10, 2013
SM TENS & PMS
Physical Medicine
333d