510(k) K253408
- Device
- CoolTone
- Applicant
- Zimmer Medizinsysteme GmbH
- 510(k) number
- K253408
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-16
- Date received
- 2025-09-30
- 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
- N
Applicant Contact#
- Contact
- Ute Killet
- Address
- Junkersstrasse 9 Neu-Elm DE 89231 89231
FDA Registration Numbers#
- 8010720
- 3009437400
- 3026753375
- 3021315370
- 3011197543
- 3007120647
- 3042268484
- 3035374386
- 3026400760
- 1832894
- 3016856381
- 3008806536
- 3027605507
- 3013602304
- 3012651177
- 2954354
- 3025367760
- 9616086
- 3015414274
- 2013558
- 3012316249
- 3043149902
- 3014314933
- 3027718340
- 2249769
- 3008753275
- 3013671142
- 3017887928
- 3004940677
- 3030970133
- 3023339107
- 3025104654
- 3045753434
- 3013917867
- 3011050674
- 3007731000
- 3015619973
- 3011564440
- 3006515340
- 3007689716
- 3015214304
- 3016674228
- 3037609256
- 3010770433
- 3005569927
- 3031233199
- 3042953831
- 3042971880
- 3010385841
- 3001431138
- 3030531253
- 3044175602
- 9613347
- 3008929787
- 3008507279
- 3007543044
- 3023808190
- 3017173524
- 1061158
- 3013957847
- 3012446970
- 3025428426
- 3024182169
- 3022929665
- 3010417025
- 3032062344
- 3013503862
- 3042641021
- 8022077
- 3027645761
- 3015977541
- 3038311114
- 3016170453
- 3004264602
- 3006850006
- 3029312829
- 2011068
- 3010880718
- 3044675848
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 |
| 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 |
| K241601 | EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | 2025-02-25 |