The following data is part of a premarket notification filed by Tyece Limited with the FDA for Tyece Otc Tens Model.
| Device ID | K200838 |
| 510k Number | K200838 |
| Device Name: | Tyece OTC TENS Model |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Tyece Limited Unit 803, Block A, Po Lung Centre, 11 Wang Chiu Rd, Kowloon Bay Kowloon, CN |
| Contact | Parshid Falahati |
| Correspondent | Maria Griffin mdi Consultants, Inc. 55 Northern Blvd, Ste 200 Great Neck, NY 11021 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-31 |
| Decision Date | 2020-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850003500713 | K200838 | 000 |
| 00850003500706 | K200838 | 000 |
| 00850003500690 | K200838 | 000 |
| 00850003500683 | K200838 | 000 |
| 10810110200217 | K200838 | 000 |