FDA 510(k) Application Details - K220217

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K220217
Device Name	Massager, Powered Inflatable Tube
Applicant	NormaTec Industries, LP 480 Pleasant Street, Suite A200 Watertown, MA 02472 US Other 510(k) Applications for this Company
Contact	Steve Henderson Other 510(k) Applications for this Contact
Regulation Number	890.5650   More FDA Info for this Regulation Number
Classification Product Code	IRP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2022
Decision Date	02/25/2022
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	Y
Expedited Review