FDA 510(k) Application Details - K213802

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K213802
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	Gimer Medical Co., Ltd. 9F.-5 and 9F.-8, No. 97, Sec. 1, Xintai 5th Road, Xizhi District New Taipei City 22175 TW Other 510(k) Applications for this Company
Contact	Rex Chang Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	GZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2021
Decision Date	08/26/2022
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