The following data is part of a premarket notification filed by Gemore Technology Co., Ltd. with the FDA for Gem-stim Tens, Models Gm3xy And Gm3axy.
| Device ID | K032720 |
| 510k Number | K032720 |
| Device Name: | GEM-STIM TENS, MODELS GM3XY AND GM3AXY |
| 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 |
| 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 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-02 |
| Decision Date | 2003-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20665973016799 | K032720 | 000 |
| 20665973016782 | K032720 | 000 |
| 20665973016775 | K032720 | 000 |
| 00816864020135 | K032720 | 000 |