510(k) K172241
- Device
- Tyece OTC EMS System, Model EM35
- Applicant
- Tyece Ltd.
- 510(k) number
- K172241
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-20
- Date received
- 2017-07-26
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Parshid Falahati
- Address
- Unit 801, Block A, Po Lung Centre, 11 Wang Chiu Rd., Kowloon Bay Kowloon HK
FDA Registration Numbers#
- 3030970133
- 3015619973
- 3045752480
- 3025428426
- 3042971880
- 3043013796
- 3009102830
- 3031464228
- 3009538657
- 3016170453
- 1832894
- 3024182169
- 3029939996
- 3020769982
- 3026164517
- 3001676837
- 8010720
- 3016674228
- 3031233197
- 3005238200
- 3003678958
- 3048246437
- 3006153348
- 3017132875
- 3008048783
- 3017146742
- 3018940143
- 3030597665
- 3010405397
- 3011191255
- 9617486
- 3011050674
- 3023330992
- 3026400760
- 3045535064
- 3010427504
- 3033881629
- 3026322014
- 3030412027
- 3008345424
- 3011466827
- 3025367760
- 3003740945
- 3007502541
- 3015282440
- 3012840029
- 3023205383
- 3011562129
- 3033844600
- 2011068
- 3010385841
- 3006807694
- 3027718340
- 3008507279
- 3016452327
- 3012134907
- 3017450375
- 3017953405
- 3013602304
- 3016670292
- 3004081884
- 3021635975
- 3014388884
- 3029924973
- 3011077581
- 3016832824
- 3017887847
- 3038311114
- 3008915316
- 3007120647
- 3033273466
- 3007615436
- 1930027
- 3042641021
- 3012729332
- 3015977541
- 3013423303
- 3015781781
- 3011564440
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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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