Shenzhen Dongdixin Technology Co., Ltd. is one of 2194 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Shenzhen Dongdixin Technology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: TECAR Therapy Device (TC2000, TC2001), TENS 7000 Rechargeable 4 Channel (TENS 7000H), ShockPhysio Mobile (model SW3200 Basic)
27
Total
27
Cleared
0
Denied
Shenzhen Dongdixin Technology Co., Ltd. has 27 FDA 510(k) cleared medical devices. Based in Shanghai, CN.
Latest FDA clearance: Oct 2026. Active since 2005. Primary specialty: Physical Medicine.
Browse the FDA 510(k) cleared devices submitted by Shenzhen Dongdixin Technology Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Regulatory Technology Services, LLC and Underwriters Laboratories, Inc..
FDA 510(k) Regulatory Record - Shenzhen Dongdixin Technology Co., Ltd.
27 devices
Cleared
Oct 13, 2026
TECAR Therapy Device (TC2000, TC2001)
General & Plastic Surgery
447d
Cleared
Jun 26, 2026
TENS 7000 Rechargeable 4 Channel (TENS 7000H)
Neurology
137d
Cleared
Jun 05, 2024
ShockPhysio Mobile (model SW3200 Basic)
Physical Medicine
120d
Cleared
Feb 25, 2022
Levator Elite (Model LE9011)
Physical Medicine
156d
Cleared
Jun 17, 2021
Migraine Tens Digital Pain Reliever
Neurology
129d
Cleared
Jun 22, 2018
Wireless Pain Relieve Device
Neurology
136d
Cleared
Mar 15, 2018
Incontinence Treatment Device, Model LT2061
Gastroenterology & Urology
304d
Cleared
Dec 08, 2017
Wireless Pain Relieve Device Model: LT5018C
Neurology
30d
Cleared
Oct 02, 2017
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
Physical Medicine
94d
Cleared
Feb 08, 2017
Smart Pain Reliever, Model LT5019
Neurology
155d
Cleared
Nov 17, 2016
Non-contact Forehead Thermometer
General Hospital
147d
Cleared
Nov 13, 2015
ComboRehab
Physical Medicine
267d