← Product Code [IKY](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/IKY) · K914921

# SCM-3 AND ACCESSORIES (K914921)

_Gaymar Industries, Inc. · IKY · Mar 12, 1992 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/IKY/K914921

## Device Facts

- **Applicant:** Gaymar Industries, Inc.
- **Product Code:** [IKY](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/IKY.md)
- **Decision Date:** Mar 12, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5150
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory Identification

A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials that have the functionally equivalent effect of supporting a patient and avoiding excess pressure on local body areas. The device is intended to treat or prevent decubitus ulcers (bed sores).

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/IKY/K914921](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/IKY/K914921)

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