FDA 510(k) Application Details - K202337

Device Classification Name	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K202337
Device Name	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Applicant	Hi-Dow International Inc. 2555 Metro Blvd Maryland Heights, MO 63043 US Other 510(k) Applications for this Company
Contact	Eric Chen 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	08/17/2020
Decision Date	12/15/2020
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