21 C.F.R. § 890.5110 Paraffin bath.
Title 21 - Food and Drugs
(a) Identification. A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) and maintained at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart F—Physical Medicine Therapeutic Devices
§ 890.5110 Paraffin bath.
