21 C.F.R. § 890.5100 Immersion hydrobath.
Title 21 - Food and Drugs
(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. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart F—Physical Medicine Therapeutic Devices
§ 890.5100 Immersion hydrobath.