CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 890—PHYSICAL MEDICINE DEVICES > SUBPART D—Physical Medicine Prosthetic Devices (§890.3025 to §890.3940) > 890.3725—Powered environmental control system.

890.3725—Powered environmental control system.

(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.

Code of Federal Regulations

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]