The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Everyway Facial Mens.
| Device ID | K142794 |
| 510k Number | K142794 |
| Device Name: | Everyway Facial MENS |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3FL, NO.5, LANE 155, SEC. 3 PERISHEN ROAD Shen Keng Hsiang, Taipei Hsien, TW 222 |
| Contact | Robert Tu |
| Correspondent | Robert Tu EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3FL, NO.5, LANE 155, SEC. 3 PERISHEN ROAD Shen Keng Hsiang, Taipei Hsien, TW 222 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-29 |
| Decision Date | 2015-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871189405 | K142794 | 000 |