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 890.5710](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5710) → IMD — Pack, Hot Or Cold, Disposable # IMD · Pack, Hot Or Cold, Disposable _Physical Medicine · 21 CFR 890.5710 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD ## Overview - **Product Code:** IMD - **Device Name:** Pack, Hot Or Cold, Disposable - **Regulation:** [21 CFR 890.5710](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5710) - **Device Class:** 1 - **Review Panel:** [Physical Medicine](/submissions/PM) ## Identification A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces. ## Classification Rationale Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9. ## Recent Cleared Devices (20 of 82) Showing 20 most recent of 82 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K221653](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K221653.md) | InfaTherm Disposable Infant Warming Mattress | International Biomedical | Oct 6, 2022 | SESE | | [K163295](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K163295.md) | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | Jul 24, 2017 | SESE | | [K112547](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K112547.md) | NEO NEST | Denovo Proucts, LLC | Mar 6, 2012 | SESE | | [K082087](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K082087.md) | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | Sep 11, 2008 | SESE | | [K071710](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K071710.md) | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | Johnson & Johnson Consumer Products, Inc. | Aug 14, 2007 | SESE | | [K021843](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K021843.md) | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | Sep 3, 2002 | SESE | | [K982652](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K982652.md) | ALLEGIANCE PORTA-WARM MATTRESS | Allegiance Healthcare Corp. | Jan 21, 1999 | SESE | | [K980509](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K980509.md) | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | Deroyal Industries, Inc. | Feb 26, 1998 | SESE | | [K974190](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K974190.md) | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | Consolidated Products & Services, Inc. | Nov 19, 1997 | SESE | | [K973770](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K973770.md) | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK | Allegiance Healthcare Corp. | Nov 13, 1997 | SESE | | [K970399](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K970399.md) | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) | Allegiance Healthcare Corp. | Apr 3, 1997 | SESE | | [K963689](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963689.md) | RECOVER ADULT VEIN WARMER | Florida Medical Industries, Inc. | Dec 12, 1996 | SESE | | [K963768](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963768.md) | INSTANT HOT PACKS | Kick Ice, Inc. | Nov 25, 1996 | SESE | | [K963666](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963666.md) | INSTANT COLD PACK | Kick Ice, Inc. | Oct 30, 1996 | SESE | | [K963220](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963220.md) | TEMPRA COLD PACK, REORDER NO. TC150 | Tempo Technology, Inc. | Oct 10, 1996 | SESE | | [K961176](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K961176.md) | OMNI COLD GEL PACKS | Omni Therm, Inc. | Sep 4, 1996 | SESE | | [K955788](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K955788.md) | IMNI HOT PACKS | Omni Therm, Inc. | Sep 4, 1996 | SESE | | [K951033](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K951033.md) | ANDELA DYNAMIC COOLING DEVICE | Candela Laser Corp. | Aug 15, 1996 | SESE | | [K960624](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K960624.md) | CERTI COOL INSTANT COLD COMPRESS | Certified Safety Mfg., Inc. | May 6, 1996 | SN | | [K954877](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K954877.md) | OMNI COLD GEL PACKS | Omni Therm, Inc. | Feb 13, 1996 | SN | ## Top Applicants - Omni Therm, Inc. — 4 clearances - Prism Technologies, Inc. — 4 clearances - Allegiance Healthcare Corp. — 3 clearances - Anago, Inc. — 3 clearances - Consolidated Products & Services, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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