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) → IRQ — Unit, Heating, Powered

# IRQ · Unit, Heating, Powered

_Physical Medicine · 21 CFR 890.5950 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ

## Overview

- **Product Code:** IRQ
- **Device Name:** Unit, Heating, Powered
- **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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K050524](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ/K050524.md) | EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 | Marda Medical, Inc. | Sep 14, 2005 | SESE |
| [K950350](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ/K950350.md) | THEMALATOR. MODELS T-4-S, T-8-S, ETC. | Whitehall/Div Columbus Mckennon Corp. | Mar 24, 1995 | SESE |
| [K924023](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ/K924023.md) | FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 | Ferno | Apr 14, 1993 | SESE |
| [K880644](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ/K880644.md) | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | Fred Sammons, Inc. | May 6, 1988 | SESE |
| [K861340](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ/K861340.md) | R1750 AND R1424 POWERED HEATING UNITS | Tri W-G, Inc. | May 2, 1986 | SESE |
| [K832177](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ/K832177.md) | PULSAIR MODEL SP-1 | Thermowave Medical Device Corp. | Dec 9, 1983 | SESE |
| [K801625](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ/K801625.md) | THERMOLATOR HEATING UNIT | Tru-Eze Mfg. Co., Inc. | Jul 28, 1980 | SESE |

## Top Applicants

- Ferno — 1 clearance
- Fred Sammons, Inc. — 1 clearance
- Marda Medical, Inc. — 1 clearance
- Thermowave Medical Device Corp. — 1 clearance
- Tri W-G, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ)

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