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Shenzhen Dongdixin Technology Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
25
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240358ShockPhysio Mobile (model SW3200 Basic)June 5, 2024
K213043Levator Elite (Model LE9011)February 25, 2022
K210364Migraine Tens Digital Pain RelieverJune 17, 2021
K180331Wireless Pain Relieve DeviceJune 22, 2018
K171430Incontinence Treatment Device, Model LT2061March 15, 2018
K173462Wireless Pain Relieve Device Model: LT5018CDecember 8, 2017
K171978Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10October 2, 2017
K162479Smart Pain Reliever, Model LT5019February 8, 2017
K161735Non-contact Forehead ThermometerNovember 17, 2016
K150436ComboRehabNovember 13, 2015
K142976UltraTENSAugust 26, 2015
K141076GARMENT ELECTRODESNovember 14, 2014
K133965OTC EMS STIMULATORJune 16, 2014
K131899SW-THERMMarch 14, 2014
K131259LASER-STIMDecember 27, 2013
K130802OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)September 16, 2013
K120217SONICSTIMU COMBO THERAPEUTIC DEVICENovember 21, 2012
K110707CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATORAugust 3, 2011
K100488IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081July 22, 2010
K093138MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003February 12, 2010