FDA 510(k) Application Details - K241509

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K241509
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Plexus Yoga LLC Dba Chirp 3900 N Traverse Mountain Blvd Suite 300 Lehi, UT 84043 US Other 510(k) Applications for this Company
Contact	Jianhua Xu 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	05/28/2024
Decision Date	06/27/2024
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