GroundRules
21 CFR 890.5760: Nonpowered lower extremity pressure wrap.
Where this section sits in the code
- 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
(a) Identification. A nonpowered lower extremity pressure wrap is a prescription device that applies mechanical pressure by wrapping around the lower extremity, such as the leg or foot, and is intended for primary Restless Leg Syndrome.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Collected 2026-08-27T02:24:47Z. Source file · JSON