510(k) K842414
- Device
- ECHO PULSE BURST
- Applicant
- RABAR, INC.
- 510(k) number
- K842414
- Product code
- GZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-07-27
- Date received
- 1984-06-19
- 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#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3023237645
- 9616309
- 1061124
- 8040537
- 3011564440
- 3005663471
- 9616086
- 2024292
- 3015588280
- 3010402752
- 3011562129
- 3027329006
- 3001431138
- 9680487
- 1000655158
- 3014315574
- 3043012074
- 2183164
- 3003573572
- 3025235024
- 3013069546
- 1000474105
- 3004558433
- 3006850006
- 3005698910
- 3008312728
- 9611612
- 3013378804
- 3011466827
- 3002809311
- 9710582
- 3008048783
- 3012316249
- 3038295706
- 1723686
- 3004049909
- 3010984291
- 3005739661
- 3009437400
- 3019822804
- 1528161
- 3004146401
- 2023152
- 3003740945
- 3030338883
- 1417592
- 3006258094
- 1062203
- 2245304
- 3007113169
- 1054713
- 3019356418
- 3008525454
- 3016508547
- 1060680
- 3010097863
- 3013671142
- 3010805941
- 3012386142
- 9613446
- 3010162782
- 3004438577
- 2032112
- 3014649088
- 3011267903
- 3006367638
- 3006791967
- 3017936974
- 3014774380
- 1000655211
- 3013591868
- 3010405397
- 3011782009
- 3023876581
- 9710567
- 3013445676
- 3009494725
- 3033847811
- 9617486
- 3011767724
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