510(k) K142794
K142794 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "Everyway Facial MENS". The FDA issued a decision of Substantially Equivalent on June 2, 2015. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Everyway Medical Instruments Co.,Ltd has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2015
- Date Received
- September 29, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type