The following data is part of a premarket notification filed by Tyece Ltd with the FDA for Tyece Otc Tens Device.
| Device ID | K150386 |
| 510k Number | K150386 |
| Device Name: | Tyece OTC TENS Device |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| 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 DRIVE Bonita Springs, FL 34135 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00050428534496 | K150386 | 000 |