Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen Dongdixin Technology Co., Ltd. has 0 FDA recalls, 3 inspections, 27 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Sep 6, 2017 · VAI
- Latest 510(k)
- Oct 13, 2026
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 27 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 6, 2017 | Nanshan, China | Devices | Voluntary Action Indicated (VAI) | 3013650048 |
| Mar 20, 2014 | Shenzhen, China | Devices | Voluntary Action Indicated (VAI) | 3005170249 |
| Dec 16, 2010 | Shenzhen, China | Devices | No Action Indicated (NAI) | 3005170249 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3013650048 | Nanshan, China | 1 | Sep 6, 2017 |
| FEI 3005170249 | Shenzhen, China | 2 | Mar 20, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K252288 | TECAR Therapy Device (TC2000, TC2001) | Oct 13, 2026 |
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Jun 26, 2026 |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | Jun 5, 2024 |
| K213043 | Levator Elite (Model LE9011) | Feb 25, 2022 |
| K210364 | Migraine Tens Digital Pain Reliever | Jun 17, 2021 |
| K180331 | Wireless Pain Relieve Device | Jun 22, 2018 |
| K171430 | Incontinence Treatment Device, Model LT2061 | Mar 15, 2018 |
| K173462 | Wireless Pain Relieve Device Model: LT5018C | Dec 8, 2017 |
| K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 | Oct 2, 2017 |
| K162479 | Smart Pain Reliever, Model LT5019 | Feb 8, 2017 |
| K161735 | Non-contact Forehead Thermometer | Nov 17, 2016 |
| K150436 | ComboRehab | Nov 13, 2015 |
| K142976 | UltraTENS | Aug 26, 2015 |
| K141076 | GARMENT ELECTRODES | Nov 14, 2014 |
| K133965 | OTC EMS STIMULATOR | Jun 16, 2014 |
| K131899 | SW-THERM | Mar 14, 2014 |
| K131259 | LASER-STIM | Dec 27, 2013 |
| K130802 | OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) | Sep 16, 2013 |
| K120217 | SONICSTIMU COMBO THERAPEUTIC DEVICE | Nov 21, 2012 |
| K110707 | CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR | Aug 3, 2011 |
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