FDA 510(k) Application Details - K192264

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K192264
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Hivox Biotek Inc. 5F., No. 123, Xinde Rd. Sanchong Dist. New Taipei City 24158 TW Other 510(k) Applications for this Company
Contact	Marx Lee Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	NGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2019
Decision Date	11/08/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review