FDA 510(k) Application Details - K131979

Device Classification Name	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K131979
Device Name	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Applicant	REGENESIS BIOMEDICAL, INC. 5301 NORTH PIMA ROAD SUITE 150 SCOTTSDALE, AZ 85250-3773 US Other 510(k) Applications for this Company
Contact	RICHARD ISENBERG Other 510(k) Applications for this Contact
Regulation Number	890.5290   More FDA Info for this Regulation Number
Classification Product Code	ILX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2013
Decision Date	12/13/2013
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