The following data is part of a premarket notification filed by Gemore Technology Co., Ltd. with the FDA for Gem-twin Tens/ Models Gm3xy/z.
| Device ID | K042559 |
| 510k Number | K042559 |
| Device Name: | GEM-TWIN TENS/ MODELS GM3XY/Z |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | GEMORE TECHNOLOGY CO., LTD. 11 FL, NO. 29-5, SEC. 2 CHUNG CHENG E. RD. Tan Shui, Taipei Hsien, TW 251 |
| Contact | Boden S.p. Lai |
| Correspondent | Boden S.p. Lai GEMORE TECHNOLOGY CO., LTD. 11 FL, NO. 29-5, SEC. 2 CHUNG CHENG E. RD. Tan Shui, Taipei Hsien, TW 251 |
| Product Code | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-21 |
| Decision Date | 2004-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24712832961144 | K042559 | 000 |
| 24712832961168 | K042559 | 000 |
| 24712832961175 | K042559 | 000 |
| 24712832961182 | K042559 | 000 |
| 24712832961199 | K042559 | 000 |
| 24712832961205 | K042559 | 000 |
| 24712832961212 | K042559 | 000 |
| 24712832961229 | K042559 | 000 |
| 24712832961236 | K042559 | 000 |
| 24712832961243 | K042559 | 000 |
| 24712832961250 | K042559 | 000 |
| 24712832961267 | K042559 | 000 |
| 24712832961274 | K042559 | 000 |
| 24712832961281 | K042559 | 000 |
| 24712832960536 | K042559 | 000 |
| 24712832961151 | K042559 | 000 |