Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5740](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5740) → IRT — Pad, Heating, Powered # IRT · Pad, Heating, Powered _Physical Medicine · 21 CFR 890.5740 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT ## Overview - **Product Code:** IRT - **Device Name:** Pad, Heating, Powered - **Regulation:** [21 CFR 890.5740](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5740) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K250047.md) | bite away two | mibeTec GmbH | Sep 12, 2025 | SESE | | [K220514](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K220514.md) | bite away neo | mibeTec GmbH | Jun 23, 2022 | SESE | | [K160943](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K160943.md) | Bite Away | Riemser Pharma | Aug 26, 2016 | SESE | | [K142228](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K142228.md) | Heated Eye Pad | Digital Heat Corporation | Feb 9, 2015 | SESE | | [K133981](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K133981.md) | AVACEN 100 | Avacen, Inc. | Aug 15, 2014 | SESE | | [K111273](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K111273.md) | FIR HEAT THERAPHY SYSYEMS | Shenzhen Anpan Technology Co., Ltd. | Nov 8, 2011 | SESE | | [K072534](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K072534.md) | BIO-MAT 2000 | Richway Intl., Inc. | Feb 8, 2008 | SESE | | [K963887](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K963887.md) | PT-PAC PORTABLE HEATING PAD | Anthony A. Chiurco | Mar 31, 1997 | SESE | | [K963824](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K963824.md) | LI'S ITCH STOPPER | Hontech Foundation For Medical Technology | Dec 12, 1996 | SESE | | [K962195](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K962195.md) | HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 | Sunbeam Health Division | Nov 27, 1996 | SESE | | [K962252](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K962252.md) | HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 | Sunbeam Health Division | Nov 25, 1996 | SESE | | [K962038](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K962038.md) | PES HOT/COLD COMPRESS | Princeton Electronic Systems, Inc. | Nov 13, 1996 | SESE | | [K924970](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K924970.md) | FEMININE HEAT WRAP | Conair Corp. | Oct 3, 1994 | SN | | [K925630](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K925630.md) | ELASTOPLAST HEAT PLASTER | Beiersdorf, Inc. | Feb 25, 1994 | SESE | | [K925820](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K925820.md) | ARTHRITIC HEAT WRAP | Conair Corp. | Feb 2, 1994 | SESE | | [K924885](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K924885.md) | KING SIZE HEAT PAD | Conair Corp. | Oct 12, 1993 | SESE | | [K924800](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K924800.md) | MOSIST HEAT PAD WITH AUTOMATIC OFF | Conair Corp. | Oct 12, 1993 | SESE | | [K924799](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K924799.md) | MOIST HEAT PAD | Conair Corp. | Oct 12, 1993 | SESE | | [K923396](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K923396.md) | THERMODYN | Nemectron Medical, Inc. | May 26, 1993 | SESE | | [K922089](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT/K922089.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com