← Product Code [IOQ](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ) · K923977

# AKROTECH 4000 (K923977)

_Lumex, Inc. · IOQ · Feb 12, 1993 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K923977

## Device Facts

- **Applicant:** Lumex, Inc.
- **Product Code:** [IOQ](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ.md)
- **Decision Date:** Feb 12, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5170
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K923977](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K923977)

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