PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
Device Facts
| Record ID | K960620 |
|---|---|
| Device Name | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM |
| Applicant | Span-America Medical Systems, Inc. |
| Product Code | FNM · General Hospital |
| Decision Date | Apr 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5550 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Indications for Use
Indicated for patients requiring prevention and treatment of pressure ulcers.
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
- PressureGuard® IV (K951112)
Related Devices
- K961159 — POWERED LOW AIR LOSS MATTRESS SYSTEM · Span-America Medical Systems, Inc. · Jun 14, 1996
- K963674 — LUMEX AIR · Lumex, Inc. · Jan 10, 1997
- K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM · Cathay Consolidated, Inc. · Nov 7, 1997
- K960188 — PRESSUREGUARD: SELECTCARE · Span-America Medical Systems, Inc. · Oct 2, 1996
- K970295 — FLEXICAIR EXLIPSE PLUS · Hill-Rom, Inc. · May 16, 1997
