510(k) K260412
- Device
- TENS 7000 Rechargeable 4 Channel (TENS 7000H)
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
- 510(k) number
- K260412
- Product code
- NUH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-26
- Date received
- 2026-02-09
- Regulation
- 882.5890
- Classification name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Siping Yuan
- Address
- Floor 1-2, #3 Bldg., Fanshen Xusheng Industrial Estate Xilixiaobaimang, Nanshan District Shenzhen CN 518108 518108
FDA Registration Numbers#
- 3009437400
- 3026753375
- 3008011951
- 3001373226
- 3042268484
- 1832894
- 3022631685
- 3008806536
- 3016856381
- 3012651177
- 3002669614
- 3025367760
- 9616086
- 2013558
- 3012316249
- 3014314933
- 2249769
- 3008585473
- 3013671142
- 3017887928
- 3021422553
- 3023339107
- 3014601569
- 3006626283
- 3011050674
- 3007731000
- 3015619973
- 3011564440
- 3015142815
- 3026264
- 3015214304
- 3007689716
- 3018514222
- 3010162782
- 3037609256
- 3010770433
- 3005569927
- 3014344342
- 3030531253
- 8030245
- 3008929787
- 3008507279
- 3007543044
- 3013957847
- 3012446970
- 3025428426
- 3022929665
- 3010417025
- 3003255790
- 3032062344
- 8022077
- 3038311114
- 3004264602
- 3006850006
- 2024292
- 3010880718
- 3023237645
- 3007710601
- 1055808
- 3014647250
- 3026322014
- 3027062656
- 3003895865
- 3004541594
- 3018940143
- 3016452327
- 3030220267
- 3026164517
- 3020769982
- 3010097863
- 3010078417
- 3009888740
- 3011120089
- 3033847811
- 3018109879
- 3007092044
- 2000004234
- 3011562129
- 3011267903
- 3001224205
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NUH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Hivox Biotek, Inc. | 2026-06-16 |
| K253896 | TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd. | 2026-03-04 |
| K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-12-31 |
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited | 2025-12-23 |
| K251958 | VEINOPLUS Back | Dynapulse Medical | 2025-12-23 |
| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2025-11-24 |
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | Everyway Medical Instruments Co.,Ltd | 2025-11-21 |
| K243131 | Triathlon Pro | Sigma Biomedical | 2025-11-07 |
| K251429 | OTC 4-Channel Rechargeable TENS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-08-28 |
| K250784 | Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) | Shenzhen Yicai Health Technology Co., Ltd. | 2025-08-21 |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-28 |
| K243856 | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) | Shenzhen Astec Technology Co., Ltd. | 2025-05-29 |
| K250360 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-05-11 |
| K250053 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-05-09 |
| K243613 | Patch-TEA (Model TRI-21) | Transtimulation Research, Inc. | 2025-04-09 |