FDA 510(k) Application Details - K240348

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K240348
Device Name	Stimulator, Muscle, Powered
Applicant	QuantumTX Pte. Ltd. 378 Alexandra Road, Alexandra Hospital, Block 29, CIH Co-Working Space Level 1 Singapore 159964 SG Other 510(k) Applications for this Company
Contact	Ivan Goh 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	02/05/2024
Decision Date	12/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review