POWERED LOW AIR LOSS MATTRESS SYSTEM
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)
Related Devices
- K960620 — PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM · Span-America Medical Systems, Inc. · Apr 25, 1996
- K963674 — LUMEX AIR · Lumex, Inc. · Jan 10, 1997
- K960188 — PRESSUREGUARD: SELECTCARE · Span-America Medical Systems, Inc. · Oct 2, 1996
- K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM · Cathay Consolidated, Inc. · Nov 7, 1997
- K970295 — FLEXICAIR EXLIPSE PLUS · Hill-Rom, Inc. · May 16, 1997
