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Data / Medical devices / China / Shenzhen Dongdixin Technology Co., Ltd.

Shenzhen Dongdixin Technology Co., Ltd.: FDA-registered device maker in SHENZHEN Guangdong, China, 16 510(k) clearances

Shenzhen Dongdixin Technology Co., Ltd. is registered with the FDA (registration 3005170249) in SHENZHEN Guangdong, China. It lists 18 device types. The FDA files 16 510(k) clearances under its listings, the newest dated June 5, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Shenzhen Dongdixin Technology Co., Ltd.
FDA registration number
3005170249
Address
Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang, Nanshan District, SHENZHEN Guangdong, China, 518108
Owner or operator
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. (9073156)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
January 19, 2010
Registered through
2026
Brand names listed
ETU-P12, TENS 7000 Massage Digital DT7202, TENS UNIT ETU-134

Devices it lists

DeviceProduct codeClassRoleSource
Cable, ElectrodeIKD2Contract manufacturer, Manufactureraccessdata.fda.gov
Clinical Electronic ThermometerSDV2Exporter to the US, Manufactureraccessdata.fda.gov
Device, BiofeedbackHCC2Manufactureraccessdata.fda.gov
Diathermy, Shortwave, For Use In Applying Therapeutic Deep HeatIMJ2Manufactureraccessdata.fda.gov
Electrode, CutaneousGXY2Manufactureraccessdata.fda.gov
Interferential Current TherapyLIH2Manufactureraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Manufactureraccessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For IncontinenceKPI2Manufactureraccessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For ArthritisNYN2Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Manufactureraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Exporter to the US, Manufactureraccessdata.fda.gov
Stimulator, Nerve, Electrical, Transcutaneous, For MigrainePCC2Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Exporter to the US, Manufactureraccessdata.fda.gov
Stimulator, Neuromuscular, External FunctionalGZI2Manufactureraccessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatIMG2Manufactureraccessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep HeatIMI2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 5, 2024K240358ShockPhysio Mobile (model SW3200 Basic)ISASubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
February 25, 2022K213043Levator Elite (Model LE9011)IPFSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
June 17, 2021K210364Migraine Tens Digital Pain RelieverPCCSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
December 8, 2017K173462Wireless Pain Relieve Device Model: LT5018CNUHSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
October 2, 2017K171978Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10IPFSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
November 13, 2015K150436ComboRehabIMGSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
August 26, 2015K142976UltraTENSIMISubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
November 14, 2014K141076GARMENT ELECTRODESGXYSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
June 16, 2014K133965OTC EMS STIMULATORNGXSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
March 14, 2014K131899SW-THERMIMJSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
December 27, 2013K131259LASER-STIMILYSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
September 16, 2013K130802OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)NUHSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
November 21, 2012K120217SONICSTIMU COMBO THERAPEUTIC DEVICEIMGSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
February 12, 2010K093138MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003IPFSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
January 29, 2010K100117LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATORIPFSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov
January 14, 2010K092627CT2011 SONICSTIMU PAIN RELIEF DEVICEIMGSubstantially EquivalentShenzhen Dongdixin Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated June 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.