(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.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Title 21 published on 2015-04-01.
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.