POWERED LOW AIR LOSS MATTRESS SYSTEM

K961159 · Span-America Medical Systems, Inc. · FNM · Jun 14, 1996 · General Hospital

Device Facts

• Record ID: K961159
• Device Name: POWERED LOW AIR LOSS MATTRESS SYSTEM
• Applicant: Span-America Medical Systems, Inc.
• Product Code: FNM · General Hospital
• Decision Date: Jun 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress with low air loss. The pressure-reducing surface is indicated for the prevention and treatment of pressure ulcers.

Device Story

Powered air flotation mattress; provides continuous air flow to internal air sacks; partial air venting within mattress; maintains inflation level for pressure reduction; used in clinical settings for pressure ulcer prevention and treatment; operated by healthcare staff; benefits patient by reducing interface pressure.

Technological Characteristics

Powered air flotation mattress; low air loss design; continuous air flow mechanism; internal air sack configuration.

Indications for Use

Indicated for patients requiring pressure ulcer prevention and treatment via powered air flotation mattress surface.

Regulatory Classification

Identification

An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• DYNAGUARD LOW AIR LOSS MATTRESS SYSTEM (K960620)

Submission Summary (Full Text)

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SPAN-AMERICA
MEDICAL SYSTEMS, INC.
K961159
JUN 14 1996

# SPAN-AMERICA HORIZONTAL LOW AIR LOSS MATTRESS SYSTEM 510K SUMMARY

1.0. SUBMITTER: Span-America Medical Systems, Inc.
ADDRESS: 70 Commerce Center; Greenville, SC 29615
TELEPHONE: [phone]
FACSIMILE: [phone]

CONTACT PERSON: Charles B. Mitchell, President & CEO
Wanda J. Totton, Director of Quality

DATE PREPARED: May 28, 1996

2.0. TRADE NAME: Span-America Horizontal Low Air Loss Mattress System

COMMON NAME: Powered Low Air Loss Mattress System
CLASSIFICATION NAME: Unknown

3.0. PREDICATE DEVICE: DYNAGUARD® LOW AIR LOSS MATTRESS SYSTEM, 510K960620

4.0. DESCRIPTION: The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air sacks as a portion of the air is vented inside the mattress. The air flow is designed to provide and maintain an inflation level to achieve pressure reduction in the prevention and treatment of pressure ulcers.

5.0. INDICATIONS FOR USE: The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress with low air loss. The pressure-reducing surface is indicated for the prevention and treatment of pressure ulcers.

6.0. SUBSTANTIAL EQUIVALENCE: The product is similar in function and intended use to the DYNAGUARD LOW AIR LOSS MATTRESS SYSTEM, 510K960620.

P.O. Box 5231, Greenville, S.C. 29606 • 803-288-8877 • FAX [phone]