510(k) K151834
- Device
- BEMER Classic Set, BEMER Pro-Set
- Applicant
- BEMER Int. AG
- 510(k) number
- K151834
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-22
- Date received
- 2015-07-06
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered, For Muscle Conditioning
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sven Bieler
- Address
- Austrasse 15 Triesen LI 9495 9495
FDA Registration Numbers#
- 3014647250
- 3033273466
- 1063974
- 3007543044
- 3010485091
- 3009102830
- 3016832824
- 3011767724
- 3022929665
- 3012386142
- 3033847811
- 9611558
- 3010417025
- 3013917867
- 3012651177
- 3011120089
- 3042190125
- 3008915316
- 3004264602
- 3027718340
- 3017173524
- 3003895865
- 3014388884
- 3027503912
- 3006793151
- 3043149902
- 3012446970
- 3023330992
- 3007092044
- 3021635975
- 3023808190
- 1528161
- 3038311114
- 3029312829
- 3023339107
- 3013423303
- 3001676837
- 3012316249
- 8040537
- 3010880718
- 3012840029
- 3015414274
- 3015619973
- 3016170453
- 3010632563
- 3005569927
- 3012725363
- 3027645761
- 3029939996
- 3003740945
- 3013889849
- 3045753434
- 3038138457
- 3013671142
- 3044675848
- 2013558
- 3009538657
- 3013503862
- 3042971880
- 1832894
- 3004183512
- 3007615436
- 3007502541
- 3012729332
- 3013957847
- 3012176966
- 3032062344
- 3043657394
- 3042351542
- 3045535064
- 3017450375
- 3015529344
- 3008770252
- 3026164517
- 3027605507
- 3033850524
- 3030531253
- 1930027
- 3011077581
Source Documents#
Other 510(k) Records For Product Code NGX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | 2026-08-13 |
| K253926 | Diacore | ShenB Co., Ltd. | 2026-04-10 |
| K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | 2026-03-12 |
| K253408 | CoolTone | Zimmer Medizinsysteme GmbH | 2026-01-16 |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-12-09 |
| K253478 | Motive™ Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | 2025-11-06 |
| K251594 | truFlex | Syrma Johari Medtech Limited | 2025-08-28 |
| K251706 | TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-30 |
| K251378 | CoolTone | Zimmer Medizinsysteme GmbH | 2025-07-14 |
| K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025-07-02 |
| K250759 | 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd. | 2025-06-13 |
| K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2025-05-30 |
| K250038 | Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-19 |
| K243165 | Limfa Therapy System (Limfa Therapy) | Eywa Srl | 2025-05-15 |
| K250146 | SofWave System | Sofwave Medical, Ltd. | 2025-04-18 |
Legacy Summary#
summary
FDA Review#
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