← Product Code [DWJ](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ) · K960511

# GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET (K960511)

_Gibeck, Inc. · DWJ · Jan 13, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K960511

## Device Facts

- **Applicant:** Gibeck, Inc.
- **Product Code:** [DWJ](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ.md)
- **Decision Date:** Jan 13, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.5900
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Device Story

Thermal regulation system; convective warming blanket. Device connects to external warming unit to deliver heated air to patient. Used in clinical settings (OR/surgical) by healthcare professionals. Provides patient warming to maintain normothermia during procedures. Reusable design.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Reusable convective warming blanket; thermal regulation system per 21 CFR 870.5900. Materials and manufacturing processes differ from predicate but maintain equivalent function.

## Regulatory Identification

A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

## Predicate Devices

- TropicAir Reusable Convective Warming Blankets (Seabrook Medical, Inc.)

## 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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{0}

JAN 13 1997

Gibeck

K960511

Subject: 510(k) Summary of Safety and Effectiveness

Product: Gibeck, Inc. Warmbag Reusable Convective Warming Blanket

## Summary:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900. These products are substantially equivalent to the TropicAir Reusable Convective Warming Blankets distributed by Seabrook Medical, Inc.

The Gibeck, Inc. Warmbag Reusable Convective Blanket is similar in design, operation and function to the Seabrook Medical, Inc. TropicAir Reusable Convective Warming Blanket.

The principal differences between the Gibeck, Inc. Warmbag Reusable Convective Warming Blanket and the Seabrook Medical, Inc. TropicAir Reusable Convective Warming Blanket are the manufacturing processes, materials and labeling. These differences are not considered to be critical to the intended therapeutic, prosthetic or surgical use of the device nor should these differences significantly affect the safety or effectiveness of the device when used as labeled.

![img-0.jpeg](img-0.jpeg)

![img-1.jpeg](img-1.jpeg)

Gibeck, Inc.

10640 East 59th Street • P.O. Box 36430 • Indianapolis, IN 46236

Telephone: (317) 823-6866 • Telefax: (317) 823-1662

A Member of the Gibeck Group

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K960511](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K960511)

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