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 890.5950](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5950) → LHC — Warmer, Irrigation Solution # LHC · Warmer, Irrigation Solution _Physical Medicine · 21 CFR 890.5950 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC ## Overview - **Product Code:** LHC - **Device Name:** Warmer, Irrigation Solution - **Regulation:** [21 CFR 890.5950](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5950) - **Device Class:** 1 - **Review Panel:** [Physical Medicine](/submissions/PM) ## Identification A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. ## Recent Cleared Devices (20 of 24) Showing 20 most recent of 24 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K153713](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K153713.md) | Getinge Series Warming Cabinet | Getinge Sourcing, LLC | Jun 7, 2016 | SESE | | [K152522](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K152522.md) | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | Ecolab, Inc. | Jan 15, 2016 | SESE | | [K150190](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K150190.md) | IntraTemp Solution Warmer | Ecolab, Inc. | Feb 26, 2015 | SESE | | [K142173](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K142173.md) | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | Ecolab, Inc. | Dec 30, 2014 | SESE | | [K142080](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K142080.md) | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED | Ecolab, Inc. | Aug 28, 2014 | SESE | | [K083417](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K083417.md) | INTRATEMP SOLUTION WARMER | C Change Surgical, LLC | Jan 13, 2009 | SESE | | [K080609](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K080609.md) | SWC/DWC WARMING CABINETS | Mac Medical | Jun 13, 2008 | SESE | | [K051819](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K051819.md) | C CHANGE SOLUTION WARMER | C Change Surgical, LLC | Aug 15, 2005 | SESE | | [K023283](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K023283.md) | 1075LD HUSH-SLUSH | O.R. Solutions, Inc. | Nov 13, 2002 | SESE | | [K023282](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K023282.md) | ORS-3000LD | O.R. Solutions, Inc. | Nov 13, 2002 | SESE | | [K021288](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K021288.md) | ORS-1000LD | O.R. Solutions, Inc. | Jun 27, 2002 | SESE | | [K021289](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K021289.md) | WARMER 2000LD | O.R. Solutions, Inc. | Jun 26, 2002 | SESE | | [K002859](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K002859.md) | SSW-STERILE SOLUTION WARMER | Kmi Kolster Methods, Inc. | Nov 16, 2000 | SESE | | [K965136](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K965136.md) | UROSURGE UROTHERM FLUID WARMING SYSTEM | Princeton Regulatory Assoc. | Oct 16, 1998 | SESE | | [K971117](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K971117.md) | WARMETTE | Olympic Medical Corp. | Aug 22, 1997 | SESE | | [K951300](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K951300.md) | NEZHAT-DORSEY THERMAL RETENTION SYSTEM | American Hydro-Surgical Instruments, Inc. | Jun 20, 1995 | SESE | | [K932538](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K932538.md) | CABOT MEDICAL IRRIGATION FLUID WARMER SETS | Cabot Medical Corp. | Feb 22, 1994 | SESE | | [K933726](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K933726.md) | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM | Augustine Medical, Inc. | Jan 28, 1994 | SESE | | [K921633](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K921633.md) | ORS-2000 SERIES | Mnlase, Inc. | Jun 2, 1992 | SESE | | [K880876](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K880876.md) | C-STAT/1000 | Sonne Medical, Inc. | May 20, 1988 | SESE | ## Top Applicants - Ecolab, Inc. — 4 clearances - O.R. Solutions, Inc. — 4 clearances - C Change Surgical, LLC — 2 clearances - American Hydro-Surgical Instruments, Inc. — 1 clearance - Augustine Medical, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC) **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. 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