Shenzhen Dongdixin Technology Co., Ltd.
SHENZHEN Guangdong, CN
Shenzhen Dongdixin Technology Co., Ltd. appears in FDA device records in SHENZHEN Guangdong, CN. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Shenzhen Dongdixin Technology Co., Ltd. between 2005 and 2026. The busiest year on record is 2010, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 4 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | NUH | Substantially Equivalent | |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | ISA | Substantially Equivalent | |
| K213043 | Levator Elite (Model LE9011) | IPF | Substantially Equivalent | |
| K210364 | Migraine Tens Digital Pain Reliever | PCC | Substantially Equivalent | |
| K180331 | Wireless Pain Relieve Device | NUH | Substantially Equivalent | |
| K171430 | Incontinence Treatment Device, Model LT2061 | KPI | Substantially Equivalent | |
| K173462 | Wireless Pain Relieve Device Model: LT5018C | NUH | Substantially Equivalent | |
| K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 | IPF | Substantially Equivalent | |
| K162479 | Smart Pain Reliever, Model LT5019 | NUH | Substantially Equivalent | |
| K161735 | Non-contact Forehead Thermometer | FLL | Substantially Equivalent | |
| K150436 | ComboRehab | IMG | Substantially Equivalent | |
| K142976 | UltraTENS | IMI | Substantially Equivalent | |
| K141076 | GARMENT ELECTRODES | GXY | Substantially Equivalent | |
| K133965 | OTC EMS STIMULATOR | NGX | Substantially Equivalent | |
| K131899 | SW-THERM | IMJ | Substantially Equivalent | |
| K131259 | LASER-STIM | ILY | Substantially Equivalent | |
| K130802 | OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) | NUH | Substantially Equivalent | |
| K120217 | SONICSTIMU COMBO THERAPEUTIC DEVICE | IMG | Substantially Equivalent | |
| K110707 | CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR | NUH | Substantially Equivalent | |
| K100488 | IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 | FLL | Substantially Equivalent | |
| K093138 | MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 | IPF | Substantially Equivalent | |
| K100117 | LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR | IPF | Substantially Equivalent | |
| K092627 | CT2011 SONICSTIMU PAIN RELIEF DEVICE | IMG | Substantially Equivalent | |
| K082057 | DX6605E-TENS, DX6605E-G, DX6609-G | GZJ | Substantially Equivalent | |
| K073366 | TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041 | FLL | Substantially Equivalent | |
| K051251 | INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 | FLL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005170249 | 3005170249 | Shenzhen Dongdixin Technology Co., Ltd. | Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang, Nanshan District,, SHENZHEN Guangdong 518108 CN | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IKDCable, Electrode
- SDVClinical Electronic Thermometer
- FLLContinuous Measurement Thermometer
- HCCDevice, Biofeedback
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- GXYElectrode, Cutaneous
- LIHInterferential Current Therapy
- ILYLamp, Infrared, Therapeutic Heating
- ISAMassager, Therapeutic, Electric
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- NYNStimulator, Electrical, Transcutaneous, For Arthritis
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- GZIStimulator, Neuromuscular, External Functional
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain