CERTI COOL INSTANT COLD COMPRESS

K960624 · Certified Safety Mfg., Inc. · IMD · May 6, 1996 · Physical Medicine

Device Facts

• Record ID: K960624
• Device Name: CERTI COOL INSTANT COLD COMPRESS
• Applicant: Certified Safety Mfg., Inc.
• Product Code: IMD · Physical Medicine
• Decision Date: May 6, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces.

Device Story

Disposable cold pack; self-contained unit; inner plastic pouch with water, outer pouch with ammonium nitrate. Activation via manual rupture of inner pouch; endothermic chemical reaction produces temperatures below 40°F for minimum 15 minutes. Used for temporary cold therapy on body surfaces. Single-use device.

Clinical Evidence

Bench testing only; device performance verified by chemical reaction temperature output (below 40°F) and duration (minimum 15 minutes).

Technological Characteristics

Plastic pouch construction; ammonium nitrate and water chemical reactants; endothermic reaction principle; single-use disposable form factor.

Indications for Use

Indicated for temporary cold therapy for body surfaces in patients requiring localized cooling.

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

• Edcool Instant Cold Pack (K871006)
• Edcool J. Instant Cold Pack (K871006)

Submission Summary (Full Text)

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Attachment # 5

# 510(k) SUMMARY

THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF THE SAFE MEDICAL DEVICE ACT OF 1990.

K960624

510(k) Summary of Safety and Effectiveness
Certi*Cool Instant Cold Compress

MAY - 6 1996

Submitted by: Certified Safety Manufacturing, Inc.
1400 Chestnut
Kansas City, MO. 64127
[phone]
Fax [phone]

Contact: Howard Gerson, Vice President
Date Prepared: February 8, 1996
Trade Name: Certi*Cool Instant Cold Compress
Common Name: Disposable Cold Pack

Classification Name: Disposable Cold Packs are classified as Class I medical devices, and are listed in 21 CFR 890.5710 as cold disposable pack.

The Certi*Cool Instant Cold Compress is substantially equivalent in design, composition and function to other disposable cold packs on the marketplace that employ a chemical reaction to produce cold. It is also substantially equivalent to our Edcool and Edcool J. Instant Cold Packs which were found SE by FDA on March 25, 1987 and assigned #K871006.

The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces. Each unit is labeled with instructions for use as well as specific warning statements. Our product consists of an inner plastic pouch containing a green-colored water and an outer pouch containing ammonium nitrate. To activate the product, simply rupture the inner pouch by using an external force, such as a fist. Then, as the two ingredients mix, a chemical reaction results by producing temperatures below 40°F for a minimum of 15 minutes. These are single use devices.