{"data":{"id":"us/21-cfr-880.5130","jurisdiction":"us","citation":"21 CFR 880.5130","heading":"Infant radiant warmer.","body":"(a) Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.\n(b) Classification. Class II (Special Controls):\n(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;\n(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and\n(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES","Subpart F—General Hospital and Personal Use Therapeutic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"b8d497f5a4855c4242a1ca46c89b23e0c697fe1497c3d49b51655a3d8449d703","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-880.5120","next":"us/21-cfr-880.5140"},"notice":"GroundRules: Original legal text. Not legal advice."}