← Product Code [IMD](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD) · K963666

# INSTANT COLD PACK (K963666)

_Kick Ice, Inc. · IMD · Oct 30, 1996 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963666

## Device Facts

- **Applicant:** Kick Ice, Inc.
- **Product Code:** [IMD](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD.md)
- **Decision Date:** Oct 30, 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 cold treatment used for first aid purposes to reduce minor local pain, swelling and discomfort.

## Device Story

Instant cold pack; consists of outer bag containing Ammonium Nitrate and inner bubble containing water; manual pressure applied to outer bag ruptures inner bubble; endothermic chemical reaction between Ammonium Nitrate and water produces cold; used for first aid; provides localized cold therapy to reduce pain, swelling, and discomfort.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Materials: polyester or laminated polyethylene bag; contents: Ammonium Nitrate and water; principle: endothermic chemical reaction; form factor: disposable pack.

## 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

- ACE Brand Instant Cold Pack (3M)
- Jack Frost

## Submission Summary (Full Text)

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Kick Ice, Inc.
P.O. Box 5519 EKS
Johnson City, Tn 37603
(423) 975-KICK

OCT 30 1996
K 96 3666

510K SUMMARY

October 16, 1996

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

Per Section 807.92(a)(3)(5), equivalency is being claimed on ACE Brand Instant Cold Pack, 3M and Jack Frost. The device provides instant cold treatment used for first aid purposes to reduce minor local pain, swelling and discomfort.

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

The Kick Ice pack consists of a bag containing Ammonium Nitrate and a liquid bubble bag containing water. The Ammonium Nitrate in the water produces a chemical reaction- When pressure is applied to the inner bubble through the outer bag the inner bubble of water opens up mixing it with the Ammonium Nitrate thereby producing cold.

The material for the bag will consist of either polyester, or laminated polyethylene.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963666](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K963666)

**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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