Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5170](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5170) → MOC — Cushion, Flotation, Therapeutic

# MOC · Cushion, Flotation, Therapeutic

_Physical Medicine · 21 CFR 890.5170 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MOC

## Overview

- **Product Code:** MOC
- **Device Name:** Cushion, Flotation, Therapeutic
- **Regulation:** [21 CFR 890.5170](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5170)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.

## 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 § 890.9.

## 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 § 890.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K063175](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MOC/K063175.md) | IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) | Medical Technology Systems, Inc. | Mar 14, 2008 | SESE |
| [K954162](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MOC/K954162.md) | ERGOSEAT SYSTEM | Ergo-Air, Inc. | Oct 30, 1995 | SESE |

## Top Applicants

- Ergo-Air, Inc. — 1 clearance
- Medical Technology Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MOC](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MOC)

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