The following data is part of a premarket notification filed by Gemore Technology Co., Ltd. with the FDA for Gem-stim Combo Stimulator.
| Device ID | K122948 |
| 510k Number | K122948 |
| Device Name: | GEM-STIM COMBO STIMULATOR |
| 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 | 2012-09-24 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815802018807 | K122948 | 000 |
| 24712832960529 | K122948 | 000 |
| 24712832960543 | K122948 | 000 |
| 24712832961441 | K122948 | 000 |
| 24712832961434 | K122948 | 000 |