{"data":{"id":"us/21-cfr-890.5710","jurisdiction":"us","citation":"21 CFR 890.5710","heading":"Hot or cold disposable pack.","body":"(a) Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.\n(b) Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 890—PHYSICAL MEDICINE DEVICES","Subpart F—Physical Medicine 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":"830d75d2ab1d040ddd277b319c2f8cec19191c465816693df1d1677d1570114c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-890.5700","next":"us/21-cfr-890.5720"},"notice":"GroundRules: Original legal text. Not legal advice."}