21 CFR 890.3725
§ 890.3725 Powered environmental control system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 890.3725, § 890.3725 Powered environmental control system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91193
- Permanent ID
ys:prov:91193@1- SHA-256
4f13cf9a0503b86bc484cf0977540f8552f45b8753674fd05f72ba094db767ca
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) 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.
(b) 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.