FDA 510(k) Applications for Medical Device Product Code "IRT"
(Pad, Heating, Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K963887 ANTHONY A. CHIURCO PT-PAC PORTABLE HEATING PAD 03/31/1997
K133981 AVACEN INC. AVACEN 100 08/15/2014
K142228 Digital Heat Corporation Heated Eye Pad 02/09/2015
K963824 HONTECH FOUNDATION FOR MEDICAL TECHNOLOGY LI'S ITCH STOPPER 12/12/1996
K220514 MibeTec, GmbH bite away neo 06/23/2022
K962038 PRINCETON ELECTRONIC SYSTEMS, INC. PES HOT/COLD COMPRESS 11/13/1996
K072534 RICHWAY INTL., INC. BIO-MAT 2000 02/08/2008
K160943 Riemser Pharma Bite Away 08/26/2016
K111273 SHENZHEN ANPAN TECHNOLOGY CO., LTD. FIR HEAT THERAPHY SYSYEMS 11/08/2011
K962252 SUNBEAM HEALTH DIVISION HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 11/25/1996
K962195 SUNBEAM HEALTH DIVISION HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 11/27/1996


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