MODEL 90022 ROLLING STAND

K963672 · Augustine Medical, Inc. · JOW · Jan 6, 1997 · Cardiovascular

Device Facts

• Record ID: K963672
• Device Name: MODEL 90022 ROLLING STAND
• Applicant: Augustine Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jan 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2

Indications for Use

The Model 90022 Rolling Stand effectively supports the Bair Hugger Model 505 Warming Unit and provides effective transportation of the unit when used under normal operating conditions.

Device Story

Rolling stand for Bair Hugger Model 505 Warming Unit; provides physical support and mobility for warming system; 5-leg base design for stability; intended for use in clinical environments; prevents tipping; restricted to use with Augustine Medical, Inc. products to ensure compatibility and safety.

Clinical Evidence

Bench testing only; stability testing performed per UL 2601-1 and IEC 601-1 standards.

Technological Characteristics

5-leg rolling stand; mechanical support structure; meets UL 2601-1 and IEC 601-1 stability requirements.

Indications for Use

Indicated for supporting and transporting the Bair Hugger Model 505 Warming Unit in clinical settings.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Reference Devices

• Bair Hugger Model 505 Warming Unit

Submission Summary (Full Text)

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F: 510(k) Summary of Safety & Effectiveness

K963672
JAN 6, 1997

# Safety

This 510(k) Summary of Safety & Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System®-Modification. The following summarizes safety issues related to the use of rolling stands and the measures to prevent these problems.

## 1. Summary of Safety:

A. Stability:

The Rolling Stand could be inadvertently tipped over.

Prevention: The Rolling Stand has 5 legs to provide additional stability and meets the stability requirements of UL 2601-1 and IEC 601-1

B. Use of stand with unapproved devices or products:

Use of the rolling stand with any device or product other than those provided by Augustine Medical, Inc. could result in damage to the stand, the attached product, or in the stand tipping over.

Prevention: Instructions packaged with the Model 90022 Rolling Stand include the statement “The Rolling Stand is not intended to be used with any device or product other than those provided by Augustine Medical, Inc.”

## 2. Summary of Effectiveness

The Model 90022 Rolling Stand effectively supports the Bair Hugger Model 505 Warming Unit and provides effective transportation of the unit when used under normal operating conditions.

Contact: Scott D. Augustine, M.D., CEO
Augustine Medical, Inc.

AUGUSTINE MEDICAL, INC.