Nonpowered lower extremity pressure wrap.

21 C.F.R. § 890.5760
in effectEffective: 2024-07-01
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(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.

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