FDA 510(k) Application Details - K243488

Device Classification Name	Massager, Therapeutic, Electric   More FDA Info for this Device
510(K) Number	K243488
Device Name	Massager, Therapeutic, Electric
Applicant	TermoSalud Altaulfo Friera Tarfe, 8 Gijon 33211 ES Other 510(k) Applications for this Company
Contact	Christina Cifuentes Pantoja Other 510(k) Applications for this Contact
Regulation Number	890.5660   More FDA Info for this Regulation Number
Classification Product Code	ISA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2024
Decision Date	02/06/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review