The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Ev-820 Otc Pain Relief Tens.
| Device ID | K151479 |
| 510k Number | K151479 |
| Device Name: | EV-820 OTC Pain Relief TENS |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL., NO. 5, Lane 155, Section 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien, TW 222 |
| Contact | Robert Tu |
| Correspondent | Robert Tu EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL., NO. 5, Lane 155, Section 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien, TW 222 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-02 |
| Decision Date | 2015-10-16 |
| Summary: | summary |