FDA 510(k) Application Details - K212342

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K212342
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	ZIIP, Inc 1425 Leimert Blvd, Suite 202 Oakland, CA 94062 US Other 510(k) Applications for this Company
Contact	David Mason Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2021
Decision Date	09/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review