IRT · Class II · 21 CFR 890.5740

FDA Product Code IRT: Pad, Heating, Powered

Leading manufacturers include Conair Corp., mibeTec GmbH and Sunbeam Health Division.

42
Total
42
Cleared
177d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 245d recently vs 175d historically

FDA 510(k) Cleared Pad, Heating, Powered Devices (Product Code IRT)

42 devices
1–24 of 42
Cleared Sep 12, 2025
bite away two
K250047
mibeTec GmbH
Physical Medicine · 245d
Cleared Jun 23, 2022
bite away neo
K220514
mibeTec GmbH
Physical Medicine · 121d
Cleared Aug 26, 2016
Bite Away
K160943
Riemser Pharma
Physical Medicine · 143d
Cleared Feb 09, 2015
Heated Eye Pad
K142228
Digital Heat Corporation
Physical Medicine · 180d
Cleared Aug 15, 2014
AVACEN 100
K133981
Avacen, Inc.
Physical Medicine · 232d
Cleared Nov 08, 2011
FIR HEAT THERAPHY SYSYEMS
K111273
Shenzhen Anpan Technology Co., Ltd.
Physical Medicine · 188d
Cleared Feb 08, 2008
BIO-MAT 2000
K072534
Richway Intl., Inc.
Physical Medicine · 154d
Cleared Mar 31, 1997
PT-PAC PORTABLE HEATING PAD
K963887
Anthony A. Chiurco
Physical Medicine · 186d
Cleared Dec 12, 1996
LI'S ITCH STOPPER
K963824
Hontech Foundation For Medical Technology
Physical Medicine · 80d
Cleared Nov 27, 1996
HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3
K962195
Sunbeam Health Division
Physical Medicine · 173d
Cleared Nov 25, 1996
HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4
K962252
Sunbeam Health Division
Physical Medicine · 166d
Cleared Nov 13, 1996
PES HOT/COLD COMPRESS
K962038
Princeton Electronic Systems, Inc.
Physical Medicine · 173d
Cleared Oct 03, 1994
FEMININE HEAT WRAP
K924970
Conair Corp.
Physical Medicine · 733d
Cleared Feb 25, 1994
ELASTOPLAST HEAT PLASTER
K925630
Beiersdorf, Inc.
Physical Medicine · 476d
Cleared Feb 02, 1994
ARTHRITIC HEAT WRAP
K925820
Conair Corp.
Physical Medicine · 442d
Cleared Oct 12, 1993
MOIST HEAT PAD
K924799
Conair Corp.
Physical Medicine · 383d
Cleared Oct 12, 1993
MOSIST HEAT PAD WITH AUTOMATIC OFF
K924800
Conair Corp.
Physical Medicine · 383d
Cleared Oct 12, 1993
KING SIZE HEAT PAD
K924885
Conair Corp.
Physical Medicine · 379d
Cleared Dec 20, 1991
SPORTS HEAT WRAP
K915241
Conair Corp.
Physical Medicine · 37d
Cleared Jul 25, 1990
INFRASSAGE MASSAGER
K902895
Conair Corp.
Physical Medicine · 22d
Cleared May 09, 1984
HYDRO-THERO PAD
K841697
Maddak, Inc.
Physical Medicine · 16d

About Product Code IRT - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code IRT since 1977, with 42 receiving FDA clearance (average review time: 177 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - IRT Product Code

Recent submissions under IRT have taken an average of 245 days to reach a decision - up from 175 days historically. Manufacturers should account for longer review timelines in current project planning.

IRT devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →