21 CFR §890.5760

1. (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.
2. (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.