510(k) K231368
- Device
- Bemer Therapy System Evo
- Applicant
- Bemer Int AG
- 510(k) number
- K231368
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-09
- Date received
- 2023-05-11
- 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
- Yes
Applicant Contact#
- Contact
- Sandra Schwarzenberger
- Address
- Austrasse 15 Triesen LI 9495 9495
FDA Registration Numbers#
- 3015781781
- 3012651177
- 3044563261
- 3044675848
- 3011564440
- 3029939996
- 3010852191
- 3042268484
- 3011562129
- 3030539046
- 2954354
- 3029924973
- 3033273466
- 3008770252
- 3006850006
- 3021635975
- 2011068
- 3023205383
- 3015977541
- 8022077
- 3026400760
- 3004146401
- 3033844600
- 3032062344
- 3016170453
- 3012725363
- 3010485091
- 1832894
- 3038311114
- 3030531253
- 3042641021
- 3013671142
- 3001676837
- 3016452327
- 3027503912
- 3027062656
- 3033847811
- 3003678958
- 2939821
- 3010632563
- 3004940677
- 9613462
- 3004264602
- 3007008050
- 3009437400
- 3015889734
- 3011050674
- 3013957847
- 3038138457
- 3044175602
- 3023339107
- 3004183512
- 3031464228
- 3005621440
- 3030970133
- 3007120647
- 3008753275
- 2013558
- 3014647250
- 3012729332
- 3030220267
- 3026753375
- 3008507279
- 3003740945
- 1061158
- 1930027
- 3015619973
- 3012316249
- 3033881629
- 3016674228
- 3005170249
- 3038620598
- 3009494725
- 3017173524
- 1063974
- 3007615436
- 3014774380
- 3010417025
- 3013917867
Source Documents#
Other 510(k) Records For Product Code NGX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243763 | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-03-12 |