← Product Code [MPO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO) · K964523

# RECOVER INFANT HEEL WARMER (5100) (K964523)

_Florida Medical Industries, Inc. · MPO · Feb 10, 1997 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K964523

## Device Facts

- **Applicant:** Florida Medical Industries, Inc.
- **Product Code:** [MPO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO.md)
- **Decision Date:** Feb 10, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5710
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine
- **Attributes:** Therapeutic, Pediatric

## Indications for Use

The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant’s heel to ensure adequate blood for sampling.

## Device Story

Disposable hot pack; used to warm infant heel prior to blood sampling. Contents: food-grade sodium acetate, water, stainless steel catalytic disc; sealed in nylon/polyethylene laminate bag. Activation via disc manipulation; provides heat to 105°F. Used in clinical settings by healthcare providers to facilitate blood collection; improves sampling success by increasing local blood flow.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Disposable hot pack; materials: food-grade sodium acetate, water, stainless steel catalytic disc, nylon/polyethylene laminate bag. Thermal energy source: exothermic crystallization triggered by catalytic disc. Form factor: flexible pouch.

## Regulatory 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.

## Predicate Devices

- Florida Medical Industries, Recover® Infant Heel Warmer (Pre 1976 Device)

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/).

{0}

K964523

FEB 10 1997

# 510(K) SUMMARY

(as required by 807.92(c))

## Submitter of 510(k):

Regulatory & Marketing Services, Inc. (RMS)
40178 U.S. 19 North
Tarpon Springs, FL 34689

Phone: 813-942-3908
Fax: 813-942-3828

## Contact Person:

Patrick J. Lamb or Edward H. Ransom

## Date of Summary:

October 18, 1996

## Trade Name:

Recover® Infant Heel Warmer

## Classification Name:

Pack, Hot, Disposable

## Predicate Device:

Florida Medical Industries, Recover® Infant Heel Warmer  Pre 1976 Device

## Device Description/ Comparison:

Non Toxic, Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon /polyethylene laminate bag. Provides heat to 105°F.

|   | Proposed Device | Marketed Device  |
| --- | --- | --- |
|   | Florida Medical Industries | Florida Medical Industries  |
|  Contents | Food-grade sodium acetate and water.
Disc: Stainless Steel Catalytic disc. | Magnesium Sulphate (Kieserite); Colloidal Clay; water.  |
|  Temp. | 105° | 105°  |

## Intended Use:

The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant’s heel to ensure adequate blood for sampling.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K964523](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MPO/K964523)

**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