eCFR Reference Browser

---

title: "21 CFR §890.5650"

source: "https://www.ecfr.gov/current/title-21/section-890.5650"

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: "890.5650"

section_subject: "Powered inflatable tube massager."

cfr_reference: "21 CFR 890.5650"

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 powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

(b)Classification. Class II (performance standards).

§890.5650 - Powered inflatable tube massager.