FDA 510(k) Applications for Medical Device Product Code "ILX"
(Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat)

FDA 510(k) Number Applicant Device Name Decision Date
K190251 BioElectronics Corporation RecoveryRx 06/28/2019
K202337 Hi-Dow International Inc. Pulsed electromagnetic field wrap 12/15/2020
K121338 IVIVI HEALTH SCIENCE, LLC ZEOBI 07/27/2012
K070541 IVIVI TECHNOLOGIES, INC. IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II 12/11/2008
K121702 ORTHOCOR MEDICAL ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE 05/06/2013
K091996 ORTHOCOR MEDICAL ORTHOCOR KNEE SYSTEM BASIC 12/15/2009
K092044 ORTHOCOR MEDICAL ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE 12/18/2009
K022404 PAW, LLC ACTIBAND 08/08/2002
K070931 PROMEDTEK, INC. MODEL PMT850 05/24/2007
K091791 REGENESIS BIOMEDICAL, INC. PROVANT SYSTEM, MODEL 4201 04/07/2010
K131979 REGENESIS BIOMEDICAL, INC. PROVANT THERAPY SYSTEM 12/13/2013
K972093 REGENESIS BIOMEDICAL, INC. REGENESIS MODEL 42 10/21/1997


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