← Product Code [FNM](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM) · K963626

# 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS (K963626)

_9th Wave, Inc. · FNM · Nov 26, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM/K963626

## Device Facts

- **Applicant:** 9th Wave, Inc.
- **Product Code:** [FNM](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM.md)
- **Decision Date:** Nov 26, 1996
- **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/K963626](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNM/K963626)

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