FDA 510(k) Application Details - K243334

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K243334
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	XF Agencija Limited Room 1502, Beverly House,93 - 107 Lockhart Road, Hong Kong 33131 CN Other 510(k) Applications for this Company
Contact	John Londergan 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	10/24/2024
Decision Date	11/22/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review