{"data":{"id":"us/21-cfr-890.5100","jurisdiction":"us","citation":"21 CFR 890.5100","heading":"Immersion hydrobath.","body":"(a) Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.\n(b) Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 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":"7ad94a6274d2b91694847faac041e8b5883607d04fd543f0db74063a8341e200","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-890.5050","next":"us/21-cfr-890.5110"},"notice":"GroundRules: Original legal text. Not legal advice."}