§ 890.5760. Nonpowered lower extremity pressure wrap.
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/us/cfr/t21/s§ 890.5760·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [79 FR 37950, July 3, 2014]