Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 890 - PHYSICAL MEDICINE DEVICES
/ Subpart D - Physical Medicine Prosthetic Devices / § 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.