Company ยท CN
Shenzhen Dongdixin Technology Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 6 |
| FLL | Continuous Measurement Thermometer | 4 |
| IPF | Stimulator, Muscle, Powered | 4 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 3 |
| GXY | Electrode, Cutaneous | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 |
| ISA | Massager, Therapeutic, Electric | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 |
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 13, 2026 | K252288 | TECAR Therapy Device (TC2000, TC2001) Shenzhen Dongdixin Technology Co., Ltd., CN | PBX |
| Jun 26, 2026 | K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Jun 5, 2024 | K240358 | ShockPhysio Mobile (model SW3200 Basic) Shenzhen Dongdixin Technology Co., Ltd., CN | ISA |
| Feb 25, 2022 | K213043 | Levator Elite (Model LE9011) Shenzhen Dongdixin Technology Co., Ltd., CN | IPF |
| Jun 17, 2021 | K210364 | Migraine Tens Digital Pain Reliever Shenzhen Dongdixin Technology Co., Ltd., CN | PCC |
| Jun 22, 2018 | K180331 | Wireless Pain Relieve Device Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Mar 15, 2018 | K171430 | Incontinence Treatment Device, Model LT2061 Shenzhen Dongdixin Technology Co., Ltd., CN | KPI |
| Dec 8, 2017 | K173462 | Wireless Pain Relieve Device Model: LT5018C Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Oct 2, 2017 | K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 Shenzhen Dongdixin Technology Co., Ltd., CN | IPF |
| Feb 8, 2017 | K162479 | Smart Pain Reliever, Model LT5019 Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Nov 17, 2016 | K161735 | Non-contact Forehead Thermometer Shenzhen Dongdixin Technology Co., Ltd., CN | FLL |
| Nov 13, 2015 | K150436 | ComboRehab Shenzhen Dongdixin Technology Co., Ltd., CN | IMG |
| Aug 26, 2015 | K142976 | UltraTENS Shenzhen Dongdixin Technology Co., Ltd., CN | IMI |
| Nov 14, 2014 | K141076 | GARMENT ELECTRODES Shenzhen Dongdixin Technology Co., Ltd., CN | GXY |
| Jun 16, 2014 | K133965 | OTC EMS STIMULATOR Shenzhen Dongdixin Technology Co., Ltd., CN | NGX |
| Mar 14, 2014 | K131899 | SW-THERM Shenzhen Dongdixin Technology Co., Ltd., CN | IMJ |
| Dec 27, 2013 | K131259 | LASER-STIM Shenzhen Dongdixin Technology Co., Ltd., CN | ILY |
| Sep 16, 2013 | K130802 | OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Nov 21, 2012 | K120217 | SONICSTIMU COMBO THERAPEUTIC DEVICE Shenzhen Dongdixin Technology Co., Ltd., CN | IMG |
| Aug 3, 2011 | K110707 | CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Jul 22, 2010 | K100488 | IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 Shenzhen Dongdixin Technology Co., Ltd., CN | FLL |
| Feb 12, 2010 | K093138 | MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 Shenzhen Dongdixin Technology Co., Ltd., CN | IPF |
| Jan 29, 2010 | K100117 | LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR Shenzhen Dongdixin Technology Co., Ltd., CN | IPF |
| Jan 14, 2010 | K092627 | CT2011 SONICSTIMU PAIN RELIEF DEVICE Shenzhen Dongdixin Technology Co., Ltd., CN | IMG |
| Feb 26, 2009 | K082057 | DX6605E-TENS, DX6605E-G, DX6609-G Shenzhen Dongdixin Technology Co., Ltd., CN | GZJ |
| Feb 8, 2008 | K073366 | TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041 Shenzhen Dongdixin Technology Co., Ltd. | FLL |
| Sep 7, 2005 | K051251 | INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 Shenzhen Dongdixin Technology Co., Ltd., CN | FLL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||