(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.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]