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IRT — Pad, Heating, Powered Class II

FDA Device Classification

Classification Details

Product Code
IRT
Device Class
Class II
Regulation Number
890.5740
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250047mibetecbite away twoSeptember 12, 2025
K220514mibetecbite away neoJune 23, 2022
K160943riemser pharmaBite AwayAugust 26, 2016
K142228digital heat corporationHeated Eye PadFebruary 9, 2015
K133981avacenAVACEN 100August 15, 2014
K111273shenzhen anpan technology coFIR HEAT THERAPHY SYSYEMSNovember 8, 2011
K072534richway intlBIO-MAT 2000February 8, 2008
K963887anthony a. chiurcoPT-PAC PORTABLE HEATING PADMarch 31, 1997
K963824hontech foundation for medical technologyLI'S ITCH STOPPERDecember 12, 1996
K962195sunbeam health divisionHEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3November 27, 1996
K962252sunbeam health divisionHEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4November 25, 1996
K962038princeton electronic systemsPES HOT/COLD COMPRESSNovember 13, 1996
K924970conairFEMININE HEAT WRAPOctober 3, 1994
K925630beiersdorfELASTOPLAST HEAT PLASTERFebruary 25, 1994
K925820conairARTHRITIC HEAT WRAPFebruary 2, 1994
K924885conairKING SIZE HEAT PADOctober 12, 1993
K924799conairMOIST HEAT PADOctober 12, 1993
K924800conairMOSIST HEAT PAD WITH AUTOMATIC OFFOctober 12, 1993
K923396nemectron medicalTHERMODYNMay 26, 1993
K922089national pain institutePNEUMATHERMFebruary 23, 1993