510(k) K901417
- Device
- ELECTROSTIM MST
- Applicant
- PROMATEK INDUSTRIES, LTD.
- 510(k) number
- K901417
- Product code
- GZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-28
- Date received
- 1990-03-26
- Regulation
- 882.5890
- Classification name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ARTHUR LEVINE
- Address
- 8390 Mayrand, Montreal Quebec, H4p 2c9 CA
FDA Registration Numbers#
- 3044563261
- 8022039
- 3027241812
- 3006791967
- 3011564440
- 3004786509
- 2032112
- 3027329006
- 3023876581
- 3008312728
- 1055808
- 3011782009
- 3011562129
- 1000655211
- 3043012240
- 3030539046
- 3012981024
- 3006367638
- 3008770252
- 3006621944
- 3013273508
- 3003836669
- 3006850006
- 3008525454
- 3005663471
- 1911273
- 3017866822
- 3013591868
- 3011506263
- 1417592
- 3014649088
- 3004839404
- 3004146401
- 1423537
- 3032062344
- 3026264
- 3004987960
- 3004558433
- 3010984291
- 3013671142
- 3011267903
- 3020160672
- 3033847811
- 9616309
- 1060680
- 3041000312
- 3002806730
- 3002669614
- 1723686
- 3009437400
- 3013069546
- 3005463575
- 3010144038
- 3003573572
- 8022189
- 3023339107
- 1721293
- 3004183512
- 3005621440
- 3013378804
- 3007719656
- 3015550326
- 3030338883
- 3037967280
- 3007661914
- 3023237645
- 2013558
- 3007113169
- 3002672225
- 3003740945
- 1061124
- 3013401749
- 2245304
- 3012440948
- 3003971136
- 3010834934
- 3015619973
- 3012316249
- 3016087653
- 3005170249
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases