Code of Federal Regulations · Section
§ 890.5740 — Powered Heating Pad
21 C.F.R. § 890.5740
View:
(a) Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.
Authorizing Statute
-
Adulterated drugs and devices21 U.S.C. § 351