510(k) K222879
- Device
- Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
- Applicant
- Wuxi Jiajian Medical Instrument Co., Ltd.
- 510(k) number
- K222879
- Product code
- GZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-24
- Date received
- 2022-09-22
- Regulation
- 882.5890
- Classification name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Wu Zhifang
- Address
- #35 Baiqiao Rd., Ehu Town, Xishan District Wuxi CN 214116 214116
FDA Registration Numbers#
- 3012184208
- 3037609256
- 3003836669
- 9617486
- 3009411292
- 9616877
- 9613446
- 3013069546
- 3026264
- 2183552
- 3015550326
- 2245304
- 3007661914
- 3037967280
- 3009494725
- 9615033
- 8040537
- 3030151584
- 3014649088
- 3005511941
- 3006258094
- 3005663471
- 3015588280
- 3025235024
- 3030338883
- 3027241812
- 3005569927
- 3011466827
- 1423537
- 3013077196
- 9710582
- 3022631685
- 3021244152
- 3002806730
- 1043214
- 3007710601
- 3027329006
- 3008879776
- 3044563261
- 3008048783
- 3005698910
- 3007719656
- 3017866822
- 3007028037
- 3008312728
- 3004049909
- 9710567
- 9614750
- 3009437400
- 3006367638
- 8022039
- 3012316249
- 3010984291
- 3043012074
- 3013401749
- 3002809311
- 3004786509
- 3011564440
- 3012251759
- 8022890
- 3010078417
- 2954348
- 3010097863
- 3005170249
- 2023152
- 3011191255
- 3004438577
- 9616309
- 2013558
- 3011506263
- 1000655158
- 1319660
- 3023876581
- 3027718340
- 3007738866
- 3014314933
- 3043012240
- 8010720
- 3011267903
- 2011115
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 |
| 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 |
| K210202 | BioWaveGO RX | Biowave Corporation | 2021-02-24 |
| K201458 | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | 2020-12-23 |
| K202159 | actiTENS | Sublimed | 2020-12-22 |