510(k) K181207
- Device
- Balego TENS Digital Edition With Accessories For Pain Relief (OTC)
- Applicant
- Everyway Medical Instruments CO., LDT.
- 510(k) number
- K181207
- Product code
- NUH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-06
- Date received
- 2018-05-07
- Regulation
- 882.5890
- Classification name
- Stimulator, Nerve, Transcutaneous, Over-the-counter
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Paul Hung
- Address
- 3 Floor , # 5, Ln. 155, Sec.3 Beishen Rd. New Taipei City TW 22203 22203
FDA Registration Numbers#
- 3011562129
- 3033530347
- 3003740945
- 3030539046
- 3014314933
- 3017887928
- 2024292
- 3008507279
- 2013558
- 3003446042
- 3005170249
- 3026322014
- 3007689716
- 3016452327
- 3008048783
- 3030531253
- 3010402752
- 3012651177
- 3025367760
- 3030597665
- 3026264
- 3001373226
- 3007719656
- 3011077581
- 3021422553
- 3009888740
- 3017953405
- 3005569927
- 3023613474
- 3007710601
- 3014647250
- 3038195193
- 1055808
- 3027062656
- 3003895865
- 1063974
- 3038295706
- 3011120089
- 2000004234
- 3014774380
- 3010078417
- 3016856381
- 3006850006
- 3023330992
- 3025428426
- 9617486
- 3010328269
- 3004541594
- 3033881629
- 3012729332
- 3008806536
- 3003255790
- 3012316249
- 3013865802
- 3011267903
- 3012725363
- 3042190125
- 3002669614
- 3008929787
- 3028172072
- 8030245
- 3001224205
- 3006469120
- 3010852191
- 8040537
- 9611558
- 3010162782
- 3010894709
- 3011191255
- 3006626283
- 3015007456
- 3019822804
- 2249769
- 3010405397
- 3023339107
- 3027241812
- 3008573045
- 3009437400
- 3017450375
Source Documents#
Other 510(k) Records For Product Code NUH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250033 | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | Guangzhou Pinzhi Medical Technology Co., Ltd. | 2025-04-07 |
Legacy Summary#
summary
FDA Review#
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