510(k) K050435
- Device
- E-STIM II
- Applicant
- LHASA OMS, INC.
- 510(k) number
- K050435
- Product code
- GZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-09-06
- Date received
- 2005-02-22
- 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
- MARK W SHEEHAN
- Address
- 230 Libbey Pkwy. Weymouth MA US 02189 02189
FDA Registration Numbers#
- 1423537
- 3010511300
- 3027718340
- 3012981024
- 1721293
- 9680487
- 3002672225
- 3015619973
- 3038197172
- 3007710601
- 3007738866
- 3022631685
- 3006791967
- 3005511941
- 8022039
- 3010805941
- 9616877
- 3032062344
- 2183164
- 9613446
- 3008312728
- 3038295706
- 3010834934
- 2020648
- 3010362721
- 3030151584
- 3004753827
- 2032112
- 3009494725
- 3008048783
- 3004786509
- 8022189
- 2245304
- 3014649088
- 3002669614
- 3006258094
- 3015588280
- 1055808
- 3012184208
- 3006367638
- 3006850006
- 3017866822
- 3013671142
- 3004987960
- 2024292
- 9612147
- 3013069546
- 3015542954
- 3017936974
- 3014314933
- 3007731000
- 1921846
- 9616086
- 3006621944
- 3027241812
- 3021244152
- 3005621440
- 1723686
- 9710616
- 3010078417
- 3025235024
- 9710582
- 3007502541
- 3006446479
- 3013273508
- 1000655158
- 1911273
- 3012440948
- 3014315574
- 2183552
- 3011782009
- 3005463575
- 3023330992
- 3012386142
- 3004558433
- 8022890
- 3009437400
- 1061124
- 1000655211
Source Documents#
Other 510(k) Records For Product Code GZJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K202159 | actiTENS | Sublimed | 2020-12-22 |
Legacy Summary#
summary
FDA Review#
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