← Product Code [FNM](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM) · K970362

# CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM (K970362)

_Apex Metal, Inc. · FNM · May 16, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM/K970362

## Device Facts

- **Applicant:** Apex Metal, Inc.
- **Product Code:** [FNM](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM.md)
- **Decision Date:** May 16, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5550
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## 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.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM/K970362](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM/K970362)

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