FDA 510(k) Application Details - K213078

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K213078
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	Johari Digital Healthcare Limited G-582, 584 EPIP, Boranda Jodhpur 342012 IN Other 510(k) Applications for this Company
Contact	Pooja Johari 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	09/23/2021
Decision Date	04/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review