Who is the manufacturer of RECOVER ADULT VEIN WARMER?

Florida Medical Industries, Inc. filed the 510(k) submission for RECOVER ADULT VEIN WARMER (K963689).

What is the FDA product code for RECOVER ADULT VEIN WARMER?

IMD. 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 ADULT VEIN WARMER?

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

Who can help prepare an FDA 510(k) submission like RECOVER ADULT VEIN WARMER?

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 ADULT VEIN WARMER

Q: What are the predicate devices for RECOVER ADULT VEIN WARMER?

Prism Technologies Instant Warm Gel.

K963689 · Florida Medical Industries, Inc. · IMD · Dec 12, 1996 · Physical Medicine

Device Facts

Record ID	K963689
Device Name	RECOVER ADULT VEIN WARMER
Applicant	Florida Medical Industries, Inc.
Product Code	IMD · Physical Medicine
Decision Date	Dec 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5710
Device Class	Class 1
Attributes	Therapeutic

Intended Use

The Recover® Instant Heat Therapy Pack is intended for use with conditions that indicate the use of heat therapy.

Device Story

Disposable hot pack; consists of food-grade sodium acetate and water solution; includes stainless steel catalytic disc; sealed in nylon bag. Activation via disc manipulation triggers exothermic crystallization; provides heat up to 112°F. Used in clinical or home settings for localized heat therapy. Output is sustained thermal energy; aids in symptom relief for heat-responsive conditions.

Clinical Evidence

Bench testing only; comparison of chemical composition and thermal output (112°F) against predicate device.

Technological Characteristics

Materials: Food-grade sodium acetate, water, stainless steel catalytic disc, nylon bag. Form factor: Disposable pack. Energy source: Exothermic chemical reaction.

Indications for Use

Indicated for patients requiring heat therapy for conditions responsive to heat application.

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

Prism Technologies Instant Warm Gel

Related Devices

K982652 — ALLEGIANCE PORTA-WARM MATTRESS · Allegiance Healthcare Corp. · Jan 21, 1999
K961154 — BAXTER SODIUM ACETATE INFANT HEEL WARMER · Baxter Healthcare Corp · Jun 6, 1996
K053254 — INFANT HEEL WARMER BY INTCO · Shanghai Intco Medical Supply Co., Ltd. · Sep 19, 2006
K963768 — INSTANT HOT PACKS · Kick Ice, Inc. · Nov 25, 1996
K964523 — RECOVER INFANT HEEL WARMER (5100) · Florida Medical Industries, Inc. · Feb 10, 1997

Submission Summary (Full Text)

{0} DEC 12 1996 510(K) SUMMARY (as required by 807.92(c)) 12 963689 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 Date of Summary: September 13, 1996 Trade Name: Recover® Instant Heat Therapy Pack Classification Name: Pack, Hot, Disposable Predicate Device: Prism Technologies Instant Warm Gel Device Description/ Comparison: Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon bag. Provides heat to 112°F. Proposed Device Marketed Device | | Florida Medical Industries | Prism Technologies | | --- | --- | --- | | Solution | Food-grade sodium acetate and water | Food-grade sodium acetate, gel and water | | Disc | Stainless Steel Catalytic disk | Stainless Steel disc | | Temp. | 112° | 112° | Intended Use: The Recover® Instant Heat Therapy Pack is intended for use with conditions that indicate the use of heat therapy.