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) → MPO — Infant Heel Warmer (Chemical Heat Pack)

# MPO · Infant Heel Warmer (Chemical Heat Pack)

_Physical Medicine · 21 CFR 890.5710 · Class 1_

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

## Overview

- **Product Code:** MPO
- **Device Name:** Infant Heel Warmer (Chemical Heat Pack)
- **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)
- **3rd-party reviewable:** yes

## 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K221154](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K221154.md) | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | Oct 7, 2022 | SESE |
| [K151845](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K151845.md) | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | Mar 18, 2016 | SESE |
| [K150627](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K150627.md) | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | May 27, 2015 | SESE |
| [K103549](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K103549.md) | DENOVO TEDDY GEL INFANT HEEL WARMER | Denovo Products, LLC | Apr 8, 2011 | SESE |
| [K053254](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K053254.md) | INFANT HEEL WARMER BY INTCO | Shanghai Intco Medical Supply Co., Ltd. | Sep 19, 2006 | SESE |
| [K040856](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K040856.md) | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER | Rapid Aid , Ltd. | May 3, 2004 | SESE |
| [K040044](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K040044.md) | HEEL SNUGGLER, MODEL 99047 | Respironics, Inc. | Jan 27, 2004 | SESE |
| [K032989](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K032989.md) | MEDI-HEAT INFANT HEEL WARMER | Mediheat, Inc. | Oct 22, 2003 | SESE |
| [K964523](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K964523.md) | RECOVER INFANT HEEL WARMER (5100) | Florida Medical Industries, Inc. | Feb 10, 1997 | SESE |
| [K961154](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K961154.md) | BAXTER SODIUM ACETATE INFANT HEEL WARMER | Baxter Healthcare Corp | Jun 6, 1996 | SESE |
| [K954716](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K954716.md) | DEROYAL INDUSTRIES INFANT HEEL WARMER | Debusk Knitting Mills, Div. Deroyal Industries | Jan 11, 1996 | SESE |

## Top Applicants

- Baxter Healthcare Corp — 1 clearance
- CooperSurgical, Inc. — 1 clearance
- Debusk Knitting Mills, Div. Deroyal Industries — 1 clearance
- Denovo Products, LLC — 1 clearance
- Florida Medical Industries, Inc. — 1 clearance

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

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