FDA 510(k) Application Details - K221443

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K221443
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	Xtreem Pulse LLC 353 W. 29 St. Suite 3 New York, NY 10001 US Other 510(k) Applications for this Company
Contact	Andrew Barile 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	05/18/2022
Decision Date	10/21/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review