← Product Code [IMD](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD) · K963689

# RECOVER ADULT VEIN WARMER (K963689)

_Florida Medical Industries, Inc. · IMD · Dec 12, 1996 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963689

## Device Facts

- **Applicant:** Florida Medical Industries, Inc.
- **Product Code:** [IMD](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD.md)
- **Decision Date:** Dec 12, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5710
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine
- **Attributes:** Therapeutic

## Indications for 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.

## 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

- Prism Technologies Instant Warm Gel

## Submission Summary (Full Text)

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{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.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963689](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963689)

**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).

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