FDA 510(k) Application Details - K213097

Device Classification Name	Pack, Hot Or Cold, Water Circulating   More FDA Info for this Device
510(K) Number	K213097
Device Name	Pack, Hot Or Cold, Water Circulating
Applicant	Pain Management Technologies, Inc. 1760 Wadsworth Rd. Akron, OH 44320 US Other 510(k) Applications for this Company
Contact	Joshua A. Lefkovitz Other 510(k) Applications for this Contact
Regulation Number	890.5720   More FDA Info for this Regulation Number
Classification Product Code	ILO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2021
Decision Date	06/10/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review