Who is the manufacturer of RECOVER INFANT HEEL WARMER (5100)?

Florida Medical Industries, Inc. filed the 510(k) submission for RECOVER INFANT HEEL WARMER (5100) (K964523).

What is the FDA product code for RECOVER INFANT HEEL WARMER (5100)?

MPO. It is classified under 21 CFR 890.5710 as a Class 1 device in the Physical Medicine panel.

What is the regulatory pathway for RECOVER INFANT HEEL WARMER (5100)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RECOVER INFANT HEEL WARMER (5100)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

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.

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)

Related Devices

K053254 — INFANT HEEL WARMER BY INTCO · Shanghai Intco Medical Supply Co., Ltd. · Sep 19, 2006
K221154 — Infant Heel WarmerTM; Heel Snuggler® · International Biomedical · Oct 7, 2022
K961154 — BAXTER SODIUM ACETATE INFANT HEEL WARMER · Baxter Healthcare Corp · Jun 6, 1996
K040856 — RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER · Rapid Aid , Ltd. · May 3, 2004
K151845 — Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) · CooperSurgical, Inc. · Mar 18, 2016

Submission Summary (Full Text)

{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.