K142794 is an FDA 510(k) clearance for the Everyway Facial MENS. This device is classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II - Special Controls, product code NFO).
Submitted by Everyway Medical Instruments Co.,Ltd (Shen Keng Hsiang, Taipei Hsien, TW). The FDA issued a Cleared decision on June 2, 2015, 246 days after receiving the submission on September 29, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K142794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2014 |
| Decision Date | June 02, 2015 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |