FDA 510(k) Application Details - K063135

Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

  More FDA Info for this Device
510(K) Number K063135
Device Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Applicant NAIMCO, INC.
4120 SOUTH CREEK ROAD
CHATTANOOGA, TN 37406 US
Other 510(k) Applications for this Company
Contact JULIE CREASMAN
Other 510(k) Applications for this Contact
Regulation Number 890.5860

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

  More FDA Info for this Product Code
Date Received 10/16/2006
Decision Date 02/05/2007
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



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