The following data is part of a premarket notification filed by Everyway Medical Instrument Co., Ltd. with the FDA for Everyway Otc Ems, Model Ev-805.
| Device ID | K162744 |
| 510k Number | K162744 |
| Device Name: | Everyway OTC EMS, Model EV-805 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | EVERYWAY MEDICAL INSTRUMENT CO., LTD. 3FL., NO. 5, LANE 155, SECTION 3, PEISHEN RD. Shenkeng Dist, New Taipei City, TW 222 |
| Contact | Paul Hung |
| Correspondent | Paul Hung EVERYWAY MEDICAL INSTRUMENT CO., LTD. 3FL., NO. 5, LANE 155, SECTION 3, PEISHEN RD. Shenkeng Dist, New Taipei City, TW 222 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-08-03 |
| Summary: | summary |