510(k) K232441
- Device
- Unipro (K-UNIPRO-US)
- Applicant
- Tenscare, Ltd.
- 510(k) number
- K232441
- Product code
- GZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-30
- Date received
- 2023-08-14
- 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
- Saskia Eldridge-Hinmers
- Address
- 9 Blenheim Rd. Epsom GB KT199BE KT199BE
FDA Registration Numbers#
- 2183552
- 3005698910
- 3037609256
- 3017264244
- 3012184208
- 3004183512
- 1528161
- 3006850006
- 3004438577
- 3005730446
- 3001431138
- 3007113169
- 3010144038
- 2013558
- 3005621440
- 3016087653
- 9616309
- 9710567
- 3006258094
- 3006435903
- 3030151584
- 3043149902
- 8022039
- 2183164
- 3006153348
- 3010362721
- 3002672225
- 3003836669
- 3009437400
- 3013445676
- 3006551156
- 9616877
- 3013077196
- 3006367638
- 3007028037
- 3003740945
- 3003446042
- 3017866822
- 9611612
- 3013917867
- 1000655158
- 3002669614
- 3014315574
- 3008525454
- 3038295706
- 3005095860
- 3005463575
- 3012316249
- 9612147
- 9614750
- 3016508547
- 3037967280
- 8022890
- 9710582
- 1000474105
- 9615033
- 3013671142
- 1061124
- 1043214
- 3004146401
- 9613446
- 3007738866
- 3005511941
- 2954348
- 3010511300
- 3010984291
- 3010405397
- 3025367760
- 3007502541
- 2245304
- 3010805941
- 3012440948
- 2020648
- 3003517662
- 1062203
- 3019356418
- 3011191255
- 3004076349
- 3011466827
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 |
| 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 |
| 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 |