510(k) K210202
- Device
- BioWaveGO RX
- Applicant
- BioWave Corporation
- 510(k) number
- K210202
- Product code
- GZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-24
- Date received
- 2021-01-25
- Regulation
- 882.5890
- Classification name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bradford Siff
- Address
- 8 Knight St., Suite 201 Norwalk CT US 06851 06851
FDA Registration Numbers#
- 3011562129
- 3003740945
- 2245304
- 3042228064
- 3030539046
- 3014314933
- 3002806730
- 2024292
- 2013558
- 9710567
- 3003446042
- 3010511300
- 1060680
- 3005170249
- 1061124
- 1723686
- 3008048783
- 1054713
- 3010402752
- 3026264
- 3025367760
- 3017866822
- 9680487
- 3007719656
- 3005569927
- 3002672225
- 3023613474
- 3007710601
- 3006153348
- 1055808
- 3003895865
- 3038295706
- 3004076349
- 3013591868
- 3014774380
- 3010078417
- 3041000312
- 3006850006
- 3023330992
- 3013378804
- 3010984291
- 3007738866
- 3030338883
- 3013273508
- 9617486
- 3030151584
- 3043012074
- 3010280625
- 3003971136
- 3043149902
- 3005095860
- 3014315574
- 3010144038
- 3012316249
- 3011267903
- 3013401749
- 3002669614
- 3027329006
- 2183164
- 8040537
- 8022189
- 3019356418
- 8022890
- 3010162782
- 3011191255
- 3002809311
- 1721293
- 9611612
- 3023876581
- 3005730446
- 1043214
- 3019822804
- 3008525454
- 3010405397
- 3023339107
- 3027241812
- 3006614152
- 2011115
- 1911273
Source Documents#
Other 510(k) Records For Product Code GZJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | 2026-05-28 |
| K252767 | actiTENS mini | Sublimed | 2026-01-16 |
| K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025-08-15 |
| K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024-08-30 |
| K241228 | TENSWave | Zynex Medical Officer | 2024-08-27 |
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited | 2024-04-19 |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2023-01-24 |
| K212618 | iRelieve Microcurrent Pain Relief System | Fast Track Technologies, Inc. | 2022-09-14 |
| K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | 2022-08-26 |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-05-25 |
| K220503 | TENS device-EmeTerm 2, Model: YF-ZTY-E2 | Wat Medical Technology, Inc. | 2022-04-23 |
| K202893 | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-06-18 |
| K202186 | TrueRelief Device | Truerelief | 2021-03-23 |
| K201458 | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | 2020-12-23 |
| K202159 | actiTENS | Sublimed | 2020-12-22 |
Legacy Summary#
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FDA Review#
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