FDA 510(k) Application Details - K220997

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K220997
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	ZMI Elecronics Ltd. 6F-1, 286-4, Shin Ya Road Kaohsiung 806 TW Other 510(k) Applications for this Company
Contact	Lawerence Liu 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	04/04/2022
Decision Date	09/01/2022
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