RECOVER INFANT HEEL WARMER (5100)

K964523 · Florida Medical Industries, Inc. · MPO · Feb 10, 1997 · Physical Medicine

Device Facts

• Record ID: K964523
• Device Name: RECOVER INFANT HEEL WARMER (5100)
• Applicant: Florida Medical Industries, Inc.
• Product Code: MPO · Physical Medicine
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• 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.

Indications for Use

Indicated for infants requiring heel stick blood sampling to enhance vasodilation and blood flow at the heel site.

Regulatory Classification

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)

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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: [phone]
Fax: [phone]

## 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.