Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Dongdixin Technology Co., Ltd. · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
153 daysmedian FDA review time
302 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | 2026-06-26 | 137 | 0 |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | Shenzhen Dongdixin Technology Co., Ltd. | 2024-06-05 | 120 | 0 |
| K213043 | Levator Elite (Model LE9011) | Shenzhen Dongdixin Technology Co., Ltd. | 2022-02-25 | 156 | 0 |
| K210364 | Migraine Tens Digital Pain Reliever | Shenzhen Dongdixin Technology Co., Ltd. | 2021-06-17 | 129 | 0 |
| K180331 | Wireless Pain Relieve Device | Shenzhen Dongdixin Technology Co., Ltd. | 2018-06-22 | 136 | 0 |
| K171430 | Incontinence Treatment Device, Model LT2061 | Shenzhen Dongdixin Technology Co., Ltd. | 2018-03-15 | 304 | 0 |
| K173462 | Wireless Pain Relieve Device Model: LT5018C | Shenzhen Dongdixin Technology Co., Ltd. | 2017-12-08 | 30 | 0 |
| K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimu | Shenzhen Dongdixin Technology Co., Ltd. | 2017-10-02 | 94 | 0 |
| K162479 | Smart Pain Reliever, Model LT5019 | Shenzhen Dongdixin Technology Co., Ltd. | 2017-02-08 | 155 | 0 |
| K161735 | Non-contact Forehead Thermometer | Shenzhen Dongdixin Technology Co., Ltd. | 2016-11-17 | 147 | 0 |
| K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | 2015-11-13 | 267 | 0 |
| K142976 | UltraTENS | Shenzhen Dongdixin Technology Co., Ltd. | 2015-08-26 | 316 | 0 |
| K141076 | GARMENT ELECTRODES | Shenzhen Dongdixin Technology Co., Ltd. | 2014-11-14 | 203 | 0 |
| K133965 | OTC EMS STIMULATOR | Shenzhen Dongdixin Technology Co., Ltd. | 2014-06-16 | 174 | 0 |
| K131899 | SW-THERM | Shenzhen Dongdixin Technology Co., Ltd. | 2014-03-14 | 262 | 0 |
| K131259 | LASER-STIM | Shenzhen Dongdixin Technology Co., Ltd. | 2013-12-27 | 239 | 0 |
| K130802 | OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) | Shenzhen Dongdixin Technology Co., Ltd. | 2013-09-16 | 178 | 0 |
| K120217 | SONICSTIMU COMBO THERAPEUTIC DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | 2012-11-21 | 302 | 0 |
| K110707 | CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIM | Shenzhen Dongdixin Technology Co., Ltd. | 2011-08-03 | 142 | 0 |
| K100488 | IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 | Shenzhen Dongdixin Technology Co., Ltd. | 2010-07-22 | 153 | 1 |
| K093138 | MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9 | Shenzhen Dongdixin Technology Co., Ltd. | 2010-02-12 | 130 | 1 |
| K100117 | LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS | Shenzhen Dongdixin Technology Co., Ltd. | 2010-01-29 | 14 | 0 |
| K092627 | CT2011 SONICSTIMU PAIN RELIEF DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | 2010-01-14 | 141 | 0 |
| K082057 | DX6605E-TENS, DX6605E-G, DX6609-G | Shenzhen Dongdixin Technology Co., Ltd. | 2009-02-26 | 220 | 0 |
| K073366 | TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1 | Shenzhen Dongdixin Technology Co., Ltd. | 2008-02-08 | 70 | 0 |
| K051251 | INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 | Shenzhen Dongdixin Technology Co., Ltd. | 2005-09-07 | 114 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda