510(k) K191075
- Device
- Healy
- Applicant
- TimeWaver Production GmbH
- 510(k) number
- K191075
- Product code
- NUH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-11-22
- Date received
- 2019-04-23
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Martin Wittmann
- Address
- Schloss Kranzlin Darritzer Strab 6 Kranzlin DE 16818 16818
FDA Registration Numbers#
- 3015007456
- 3015214304
- 3010880718
- 3007719656
- 3026322014
- 3010097863
- 3023613474
- 3005170249
- 3012840029
- 8030245
- 3008806536
- 3025367760
- 3012651177
- 3030412027
- 3017887847
- 3038295706
- 3006367638
- 2248223
- 3007615436
- 3010894709
- 3012729332
- 3006850006
- 3004183512
- 3010078417
- 3025235024
- 3014647250
- 9611558
- 3012134907
- 3009437400
- 3003741676
- 3009411292
- 3018940143
- 9616086
- 3011767724
- 3016452327
- 3005569927
- 3008973759
- 3030597665
- 3016856381
- 3042190125
- 3006469120
- 3012176966
- 3016508547
- 3006551156
- 3004049909
- 1832894
- 2024292
- 3038620598
- 3006153348
- 2249769
- 3039394880
- 3009488655
- 3001224205
- 2000004234
- 3008929787
- 3015142815
- 3010632563
- 3042268484
- 3008011951
- 3027241812
- 3031464228
- 3004146401
- 3003740945
- 9617486
- 3038311114
- 3018109879
- 3009888740
- 3017450375
- 3013865802
- 3023330992
- 3030539046
- 3004839404
- 3032062344
- 3012316249
- 3017953405
- 3030531253
- 3015588280
- 3014601569
- 2013558
Source Documents#
Other 510(k) Records For Product Code NUH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261574 | Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) | Hong Qiangxing (Shenzhen) Electronics Limited | 2026-10-16 |
| K261131 | Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.) | Shenzhen Osto Medical Technology Co.,Ltd | 2026-09-06 |
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | 2026-06-26 |
| 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 |
| K251958 | VEINOPLUS Back | Dynapulse Medical | 2025-12-23 |
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited | 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 |
Legacy Summary#
summary
FDA Review#
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