Regulation Text
(a) Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.
(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 .
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.