The following data is part of a premarket notification filed by Gimer Medical Co., Ltd. with the FDA for Stimontm Pain Relief System (gm2439).
| Device ID | K213802 |
| 510k Number | K213802 |
| Device Name: | StimOnTM Pain Relief System (GM2439) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | Gimer Medical Co., Ltd. 9F.-5 And 9F.-8, No. 97, Sec. 1, Xintai 5th Road, Xizhi District New Taipei City, TW 22175 |
| Contact | Rex Chang |
| Correspondent | Anita Chen ZhengCheng Limited Company 238 No.19. 335 Lane, Fu-Xi Road, Shulin District New Taipei City, TW 238 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-06 |
| Decision Date | 2022-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873360093 | K213802 | 000 |