§ 890.5575 — Powered External Limb Overload Warning Device

(a) Identification. A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.

(b) Classification. Class II (special 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.