The following data is part of a premarket notification filed by Gemore Technology Co Ltd with the FDA for Gim-stim Otc Tens/ems System.
| Device ID | K190988 |
| 510k Number | K190988 |
| Device Name: | GIM-STIM OTC TENS/EMS System |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Gemore Technology Co Ltd 11FL., No.29-5, Sec.2, Chug Cheng E. RD., Tan Shui, New Taipei City, TW 251 |
| Contact | Boden S.p. Lai |
| Correspondent | Boden S.p. Lai Gemore Technology Co Ltd 11FL., No.29-5, Sec.2, Chug Cheng E. RD., Tan Shui, New Taipei City, TW 251 |
| Product Code | NUH |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-15 |
| Decision Date | 2019-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24712832961489 | K190988 | 000 |
| 24712832961502 | K190988 | 000 |
| 24712832961519 | K190988 | 000 |
| 24712832961526 | K190988 | 000 |
| 24712832961533 | K190988 | 000 |
| 24712832961540 | K190988 | 000 |
| 24712832961557 | K190988 | 000 |
| 24712832961564 | K190988 | 000 |
| 24712832961571 | K190988 | 000 |
| 24712832961588 | K190988 | 000 |
| 24712832961595 | K190988 | 000 |
| 24712832961601 | K190988 | 000 |
| 24712832961618 | K190988 | 000 |
| 24712832961625 | K190988 | 000 |
| 24712832961496 | K190988 | 000 |