FNM · Mattress, Air Flotation, Alternating Pressure
General Hospital · 21 CFR 880.5550 · Class 2
Overview
| Product Code | FNM |
|---|---|
| Device Name | Mattress, Air Flotation, Alternating Pressure |
| Regulation | 21 CFR 880.5550 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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).
Classification Rationale
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.
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.
Recent Cleared Devices (20 of 102)
Showing 20 most recent of 102 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973169 | PRESSURE GUARD SITE SELECT (A) | Span-America Medical Systems, Inc. | Feb 20, 1998 | SESE |
| K974319 | MIGHTY AIR | Wheelchairs of Kansas | Jan 22, 1998 | SESE |
| K972022 | ZAK-2000 | Cardio Systems, Inc. | Jan 22, 1998 | SESE |
| K974070 | PHYSIO/1000 | Physio Designs, Inc. | Jan 6, 1998 | SESE |
| K972549 | SIMPULSE | Kinetic Concepts, Inc. | Nov 18, 1997 | SESE |
| K970081 | SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM | Cathay Consolidated, Inc. | Nov 7, 1997 | SESE |
| K955243 | BARIAIR | Kinetic Concepts, Inc. | Oct 23, 1997 | SESE |
| K970468 | KT AIR BED | Kinetic Concepts, Inc. | Sep 5, 1997 | SESE |
| K965207 | RID-DECUBE II | Skin Care Management, Inc. | Aug 21, 1997 | SESE |
| K972153 | ALTERNATING PRESSURE AIR FLOTATION MATTRESS | Decubiti Concepts, Inc. | Jul 31, 1997 | SESE |
| K971568 | REST MATTRESS | Rest Mattress | Jul 18, 1997 | SESE |
| K954320 | MODIFIED PEDIKAIR | Kinetic Concepts, Inc. | Jul 18, 1997 | SESE |
| K970362 | CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM | Apex Metal, Inc. | May 16, 1997 | SESE |
| K970428 | REST X SYSTEM | Restxsys | May 14, 1997 | SESE |
| K970350 | EQUI-PISE 1000 MRS | Advanced Air Support Consultancy, Inc. | Apr 22, 1997 | SESE |
| K963674 | LUMEX AIR | Lumex, Inc. | Jan 10, 1997 | SESE |
| K963620 | 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS | 9th Wave, Inc. | Jan 7, 1997 | SESE |
| K962585 | UNIT-MATT 5000 PRESSURE RELIEF SYSTEM | United Medical Equipment, Inc. | Jan 7, 1997 | SESE |
| K963677 | 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD | 9th Wave, Inc. | Nov 26, 1996 | SESE |
| K963626 | 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS | 9th Wave, Inc. | Nov 26, 1996 | SESE |
Top Applicants
- Kinetic Concepts, Inc. — 8 clearances
- Span-America Medical Systems, Inc. — 8 clearances
- Huntleigh Technology, Inc. — 5 clearances
- 9th Wave, Inc. — 3 clearances
- Gaymar Industries, Inc. — 3 clearances
