FDA 510(k) Application Details - K121338

Device Classification Name	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K121338
Device Name	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Applicant	IVIVI HEALTH SCIENCE, LLC 330 TOWNSEND STREET SUITE 100 SAN FRANCISCO, CA 94107 US Other 510(k) Applications for this Company
Contact	KATHRYN CLUBB 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	05/03/2012
Decision Date	07/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review