← Product Code [FNM](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM) · K960620

# PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM (K960620)

_Span-America Medical Systems, Inc. · FNM · Apr 25, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM/K960620

## Device Facts

- **Applicant:** Span-America Medical Systems, Inc.
- **Product Code:** [FNM](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM.md)
- **Decision Date:** Apr 25, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5550
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

For the prevention and treatment of pressure ulcers.

## Device Story

Powered air flotation mattress system; provides continuous airflow to internal air cylinders; vents portion of air inside mattress; maintains inflation levels for pressure reduction; used in clinical settings for pressure ulcer management; assists healthcare providers in wound care; benefits patients by reducing interface pressure to prevent or treat skin breakdown.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Powered air flotation mattress; utilizes air cylinders with continuous airflow and venting mechanism; electrical energy source; standalone system.

## Regulatory 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

- PressureGuard® IV ([K951112](/device/K951112.md))

## Submission Summary (Full Text)

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{0}

SPAN-AMERICA
MEDICAL SYSTEMS, INC.
K960620
K960620
APR 25 1996

PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
510K SUMMARY

1.0 SUBMITTER: Span-America Medical Systems, Inc.
ADDRESS: 70 Commerce Center; Greenville, SC 29615
TELEPHONE: 864/288-8877
FACSIMILE: 864/288-8692

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

DATE PREPARED: February 8, 1996

2.0 TRADE NAME: PressureGuard: Low Air Loss Mattress System
COMMON NAME: Powered Low Air Loss Mattress System
CLASSIFICATION NAME: Unknown

3.0 PREDICATE DEVICE: PressureGuard® IV, 510K951112.

4.0 DESCRIPTION: The PressureGuard Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air cylinders 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: For the prevention and treatment of pressure ulcers.

6.0 SUBSTANTIAL EQUIVALENCE: The product is similar in function and intended use to the PressureGuard® IV, 510K951112 for the Center Mode.

A WPWINTOTTONIS10KLOW AIR
P.O. Box 5231, Greenville, S.C. 29606 • 803-288-8877 • FAX 803-288-8692

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM/K960620](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM/K960620)

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