FDA 510(k) Application Details - K182581

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K182581
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	PlayMakar Inc. 1603 Hart Street Southlake, TX 76092 US Other 510(k) Applications for this Company
Contact	Mike Williams 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	09/19/2018
Decision Date	11/21/2018
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	N
Expedited Review