RECOVER ADULT VEIN WARMER

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

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: [phone]
Fax: [phone]

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.