510(k) K142794

Everyway Facial MENS by Everyway Medical Instruments Co.,Ltd — Product Code NFO

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