Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K260412	TENS 7000 Rechargeable 4 Channel (TENS 7000H)	NUH	2026-06-26	View
510(k)	K240358	ShockPhysio Mobile (model SW3200 Basic)	ISA	2024-06-05	View
510(k)	K213043	Levator Elite (Model LE9011)	IPF	2022-02-25	View
510(k)	K210364	Migraine Tens Digital Pain Reliever	PCC	2021-06-17	View
510(k)	K180331	Wireless Pain Relieve Device	NUH	2018-06-22	View
510(k)	K171430	Incontinence Treatment Device, Model LT2061	KPI	2018-03-15	View
510(k)	K173462	Wireless Pain Relieve Device Model: LT5018C	NUH	2017-12-08	View
510(k)	K171978	Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10	IPF	2017-10-02	View
510(k)	K162479	Smart Pain Reliever, Model LT5019	NUH	2017-02-08	View
510(k)	K161735	Non-contact Forehead Thermometer	FLL	2016-11-17	View
510(k)	K131259	LASER-STIM	ILY	2013-12-27	View
510(k)	K130802	OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)	NUH	2013-09-16	View
510(k)	K120217	SONICSTIMU COMBO THERAPEUTIC DEVICE	IMG	2012-11-21	View
510(k)	K110707	CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR	NUH	2011-08-03	View
510(k)	K100488	IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081	FLL	2010-07-22	View
510(k)	K093138	MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003	IPF	2010-02-12	View
510(k)	K100117	LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR	IPF	2010-01-29	View
510(k)	K092627	CT2011 SONICSTIMU PAIN RELIEF DEVICE	IMG	2010-01-14	View
510(k)	K082057	DX6605E-TENS, DX6605E-G, DX6609-G	GZJ	2009-02-26	View
510(k)	K073366	TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041	FLL	2008-02-08	View