FDA 510(k) Application Details - K181759

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K181759
Device Name	Stimulator, Muscle, Powered
Applicant	Smartmissimo Technologies Pte Ltd #28-01, SGX Centre II, 4 Shenton Way Singapore 068807 SG Other 510(k) Applications for this Company
Contact	Alexey Pisarev Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	IPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2018
Decision Date	11/09/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review