← Product Code [LHC](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC) · K921633

# ORS-2000 SERIES (K921633)

_Mnlase, Inc. · LHC · Jun 2, 1992 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K921633

## Device Facts

- **Applicant:** Mnlase, Inc.
- **Product Code:** [LHC](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC.md)
- **Decision Date:** Jun 2, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5950
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K921633](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LHC/K921633)

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