Medical Device Manufacturer · CN , Shanghai

Shenzhen Dongdixin Technology Co., Ltd. - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 2005

Recent clearances: ShockPhysio Mobile (model SW3200 Basic), Levator Elite (Model LE9011), Migraine Tens Digital Pain Reliever

25
Total
25
Cleared
0
Denied

Shenzhen Dongdixin Technology Co., Ltd. has 25 FDA 510(k) cleared medical devices. Based in Shanghai, CN.

Latest FDA clearance: Jun 2024. 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.

FDA 510(k) Regulatory Record - Shenzhen Dongdixin Technology Co., Ltd.

25 devices
1-25 of 25
Cleared Jun 05, 2024
ShockPhysio Mobile (model SW3200 Basic)
K240358 · ISA
Physical Medicine · 120d
Cleared Feb 25, 2022
Levator Elite (Model LE9011)
K213043 · IPF
Physical Medicine · 156d
Cleared Jun 17, 2021
Migraine Tens Digital Pain Reliever
K210364 · PCC
Neurology · 129d
Cleared Jun 22, 2018
Wireless Pain Relieve Device
K180331 · NUH
Neurology · 136d
Cleared Mar 15, 2018
Incontinence Treatment Device, Model LT2061
K171430 · KPI
Gastroenterology & Urology · 304d
Cleared Dec 08, 2017
Wireless Pain Relieve Device Model: LT5018C
K173462 · NUH
Neurology · 30d
Cleared Oct 02, 2017
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978 · IPF
Physical Medicine · 94d
Cleared Feb 08, 2017
Smart Pain Reliever, Model LT5019
K162479 · NUH
Neurology · 155d
Cleared Nov 17, 2016
Non-contact Forehead Thermometer
K161735 · FLL
General Hospital · 147d
Cleared Nov 13, 2015
ComboRehab
K150436 · IMG
Physical Medicine · 267d
Cleared Aug 26, 2015
UltraTENS
K142976 · IMI
Physical Medicine · 316d
Cleared Nov 14, 2014
GARMENT ELECTRODES
K141076 · GXY
Neurology · 203d
Cleared Jun 16, 2014
OTC EMS STIMULATOR
K133965 · NGX
Physical Medicine · 174d
Cleared Mar 14, 2014
SW-THERM
K131899 · IMJ
Physical Medicine · 262d
Cleared Dec 27, 2013
LASER-STIM
K131259 · ILY
Physical Medicine · 239d
Cleared Sep 16, 2013
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
K130802 · NUH
Neurology · 178d
Cleared Nov 21, 2012
SONICSTIMU COMBO THERAPEUTIC DEVICE
K120217 · IMG
Physical Medicine · 302d
Cleared Aug 03, 2011
CARE BACK PAIN RELIEF STIMULATOR
K110707 · NUH
Neurology · 142d
Cleared Jul 22, 2010
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
K100488 · FLL
General Hospital · 153d
Cleared Feb 12, 2010
MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND...
K093138 · IPF
Physical Medicine · 130d
Cleared Jan 29, 2010
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR
K100117 · IPF
Physical Medicine · 14d
Cleared Jan 14, 2010
CT2011 SONICSTIMU PAIN RELIEF DEVICE
K092627 · IMG
Physical Medicine · 141d
Cleared Feb 26, 2009
DX6605E-TENS, DX6605E-G, DX6609-G
K082057 · GZJ
Neurology · 220d
Cleared Feb 08, 2008
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041
K073366 · FLL
General Hospital · 70d
Cleared Sep 07, 2005
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
K051251 · FLL
General Hospital · 114d
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