The following data is part of a premarket notification filed by Tyece Ltd. with the FDA for Tyece Otc Ems System.
| Device ID | K183454 |
| 510k Number | K183454 |
| Device Name: | Tyece OTC EMS System |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Tyece Ltd. Unit 801, Block A, Po Lung Centre, 11 Wang Chiu Rd. Kowloon Bay Kowloon, Hong Kong, HK |
| Contact | Parshid Falahati |
| Correspondent | Guenter Ginsberg Media Trade Corporation 11820 Red Hibiscus Dr Bonita Springs, FL 34135 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-13 |
| Decision Date | 2019-02-26 |