21 C.F.R. § 890.5760

Current through September 30, 2024
Section 890.5760 - Nonpowered lower extremity pressure wrap
(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 .

21 C.F.R. §890.5760

79 FR 37950, July 3, 2014