The following data is part of a premarket notification filed by Gemore Technology Co., Ltd. with the FDA for Gm3 Series If Tens, Model Gm3x2if (where X Is A Parameter Of Different Housing).
| Device ID | K032719 |
| 510k Number | K032719 |
| Device Name: | GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) |
| 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 |
| 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 | LIH |
| 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 |
|---|---|---|
| 20815802010027 | K032719 | 000 |