eCFR Reference Browser

---

title: "21 CFR §890.5110"

source: "https://www.ecfr.gov/current/title-21/section-890.5110"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "890"

part_subject: "PHYSICAL MEDICINE DEVICES"

subpart_code: "F"

subpart_subject: "Physical Medicine Therapeutic Devices"

section_number: "890.5110"

section_subject: "Paraffin bath."

cfr_reference: "21 CFR 890.5110"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§890.5110 - Paraffin bath.