← Product Code [FOH](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOH) · K812683

# NEONATE FLEXFLOAT (K812683)

_Pharmaquest Corp. · FOH · Oct 13, 1981 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOH/K812683

## Device Facts

- **Applicant:** Pharmaquest Corp.
- **Product Code:** [FOH](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOH.md)
- **Decision Date:** Oct 13, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5560
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory Identification

A temperature regulated water mattress is a device intended for medical purposes that consists of a mattress of suitable size, filled with water which can be heated or in some cases cooled. The device includes electrical heating and water circulating components, and an optional cooling component. The temperature control may be manual or automatic.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOH/K812683](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOH/K812683)

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