IRT · Pad, Heating, Powered
Physical Medicine · 21 CFR 890.5740 · Class 2
Overview
| Product Code | IRT |
|---|---|
| Device Name | Pad, Heating, Powered |
| Regulation | 21 CFR 890.5740 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (20 of 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250047 | bite away two | mibeTec GmbH | Sep 12, 2025 | SESE |
| K220514 | bite away neo | mibeTec GmbH | Jun 23, 2022 | SESE |
| K160943 | Bite Away | Riemser Pharma | Aug 26, 2016 | SESE |
| K142228 | Heated Eye Pad | Digital Heat Corporation | Feb 9, 2015 | SESE |
| K133981 | AVACEN 100 | Avacen, Inc. | Aug 15, 2014 | SESE |
| K111273 | FIR HEAT THERAPHY SYSYEMS | Shenzhen Anpan Technology Co., Ltd. | Nov 8, 2011 | SESE |
| K072534 | BIO-MAT 2000 | Richway Intl., Inc. | Feb 8, 2008 | SESE |
| K963887 | PT-PAC PORTABLE HEATING PAD | Anthony A. Chiurco | Mar 31, 1997 | SESE |
| K963824 | LI'S ITCH STOPPER | Hontech Foundation For Medical Technology | Dec 12, 1996 | SESE |
| K962195 | HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 | Sunbeam Health Division | Nov 27, 1996 | SESE |
| K962252 | HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 | Sunbeam Health Division | Nov 25, 1996 | SESE |
| K962038 | PES HOT/COLD COMPRESS | Princeton Electronic Systems, Inc. | Nov 13, 1996 | SESE |
| K924970 | FEMININE HEAT WRAP | Conair Corp. | Oct 3, 1994 | SN |
| K925630 | ELASTOPLAST HEAT PLASTER | Beiersdorf, Inc. | Feb 25, 1994 | SESE |
| K925820 | ARTHRITIC HEAT WRAP | Conair Corp. | Feb 2, 1994 | SESE |
| K924885 | KING SIZE HEAT PAD | Conair Corp. | Oct 12, 1993 | SESE |
| K924800 | MOSIST HEAT PAD WITH AUTOMATIC OFF | Conair Corp. | Oct 12, 1993 | SESE |
| K924799 | MOIST HEAT PAD | Conair Corp. | Oct 12, 1993 | SESE |
| K923396 | THERMODYN | Nemectron Medical, Inc. | May 26, 1993 | SESE |
| K922089 | PNEUMATHERM | National Pain Institute | Feb 23, 1993 | SESE |
Top Applicants
- Conair Corp. — 7 clearances
- Sunbeam Health Division — 2 clearances
- The Gillette Company — 2 clearances
- mibeTec GmbH — 2 clearances
- Acurex Aerotherm — 1 clearance
