The following data is part of a premarket notification filed by Gemore Technology Co., Ltd. with the FDA for Gemore Otc Tens.
| Device ID | K150681 |
| 510k Number | K150681 |
| Device Name: | GEMORE OTC TENS |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | GEMORE TECHNOLOGY CO., LTD. 11 FL., No.29-5, Sec.2, Chung Cheng E. RD., Tan Shui, New Taipei City, 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, New Taipei City, TW 251 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-17 |
| Decision Date | 2015-05-12 |
| Summary: | summary |