FDA 510(k) Application Details - K243613

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K243613
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Transtimulation Research, Inc 800 Research Parkway, # 337 Oklahoma City, OK 73104 US Other 510(k) Applications for this Company
Contact	Victor Pikov 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	11/22/2024
Decision Date	04/09/2025
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