The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Everyway Otc Tens/ems Combination.
| Device ID | K192589 |
| 510k Number | K192589 |
| Device Name: | Everyway OTC TENS/EMS Combination |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL., NO. 5, Lane 155, Section 3, Peishen Rd., Shenkeng District, New Taipei City, TW 22203 |
| Contact | Paul Hung |
| Correspondent | Paul Hung EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL., NO. 5, Lane 155, Section 3, Peishen Rd., Shenkeng District, New Taipei City, TW 22203 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-20 |
| Decision Date | 2019-12-19 |