StacksVerified U.S. regulatory reference

21 CFR §890.3725

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.