FDA 510(k) Application Details - K242460

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K242460
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Progenix LLC Department 114 10304 Eaton Place, Suite 100 Fairfax, VA 22030 US Other 510(k) Applications for this Company
Contact	Christian Hunt Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2024
Decision Date	04/02/2025
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