FDA 510(k) Application Details - K142228

Device Classification Name Pad, Heating, Powered

  More FDA Info for this Device
510(K) Number K142228
Device Name Pad, Heating, Powered
Applicant Digital Heat Corporation
5626 S. Captain Kidd Ct. Unit B
Tempe, AZ 85283 US
Other 510(k) Applications for this Company
Contact John Devine
Other 510(k) Applications for this Contact
Regulation Number 890.5740

  More FDA Info for this Regulation Number
Classification Product Code IRT
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/13/2014
Decision Date 02/09/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact