← Product Code [IMD](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD) · K963768

# INSTANT HOT PACKS (K963768)

_Kick Ice, Inc. · IMD · Nov 25, 1996 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963768

## Device Facts

- **Applicant:** Kick Ice, Inc.
- **Product Code:** [IMD](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD.md)
- **Decision Date:** Nov 25, 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 device provides instant hot treatment used for first aid purposes to reduce local pain and discomfort.

## Device Story

Instant hot pack; provides localized heat therapy for first aid; reduces pain and discomfort; disposable; used in clinical or home settings; operated by patient or caregiver; provides therapeutic heat via chemical reaction; benefits patient through non-invasive pain management.

## Clinical Evidence

No clinical data; reliance on 32-year market history of similar hot therapy applications.

## Technological Characteristics

Disposable chemical heat pack; 21 CFR 890.5710 classification; non-powered; manual activation.

## 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

- Jack Frost Laboratories Instant Hot Pack

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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KICK ICE, INC.
P.O. Box 5519 EKS
Johnson City, Tn 37603
(423) 975-KICK

NOV 25 1996
L963768

510K SUMMARY

September 19, 1996

TRADE NAME: INSTANT HOT PACK
COMMON NAME: INSTANT HOT PACK
CLASSIFICATION NAME: HOT OR COLD
DISPOSABLE PACK 890.5710

Per Section 807.92(a)(3)(5), equivalency is being claimed on Jack Frost Laboratories Instant Hot Pack. The device provides instant hot treatment used for first aid purposes to reduce local pain and discomfort.

This type of hot therapy application has been on the market for approximately 32 years and has proven to be a safe and effective way for giving medical attention wherever heat therapy is indicated.

Our contact is Victoria M. Phillips at (800) 833-7678.

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KICK THE ICE HABIT

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963768](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963768)

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