The following data is part of a premarket notification filed by Gemore Technology Co., Ltd. with the FDA for Gemore True Sine Interferential Stimulator.
| Device ID | K122944 |
| 510k Number | K122944 |
| Device Name: | GEMORE TRUE SINE INTERFERENTIAL STIMULATOR |
| Classification | Interferential Current Therapy |
| 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 | 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 |
|---|---|---|
| 24712832960475 | K122944 | 000 |
| 24712832961427 | K122944 | 000 |
| 24712832961410 | K122944 | 000 |
| 24712832961403 | K122944 | 000 |