← Product Code [IQA](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA) · K921528

# HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM (K921528)

_Hill-Rom, Inc. · IQA · Apr 20, 1992 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K921528

## Device Facts

- **Applicant:** Hill-Rom, Inc.
- **Product Code:** [IQA](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA.md)
- **Decision Date:** Apr 20, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3725
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A powered environmental control system is an AC- or battery-powered device intended for medical purposes that is used by a patient to operate an environmental control function. Examples of environmental control functions include the following: to control room temperature, to answer a doorbell or telephone, or to sound an alarm for assistance.

## 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-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K921528](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQA/K921528)

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