(173 days)
Use wherever hot applications are desirable for personal comfort, and wherever recommended by your physician, dentist or health care professional for the relief of minor muscular or joint pain.
Electric Heating Pad, 11.5" x 14.5" conforming to ANSI / UL Standard #130, Electric Heating Pads, operating on standard 110-120V household current. The units are supplied with removable covers and sponge inserts for moist heat applications, with instructions, in conventional 4-color printed boxes, and are marketed through consumer retail channels.
This document is a 510(k) summary for electric heating pads (Models EHP2, EHP3). It details the product's classification, description, and intended use. However, it does not contain any information about acceptance criteria, device performance, sample sizes, expert involvement, or study methodologies that would typically be found in a clinical or performance study report.
The document's purpose is to claim "substantial equivalence" of the new heating pads to existing, legally marketed devices. It explicitly states that "Substantial equivalence is claimed because: the power source, manufacturing technology, operating principles, intended uses and safety standards are the same for all models. Differences are primarily cosmetic."
Therefore, I cannot extract the requested information as it is not present in the provided text. This type of submission relies on demonstrating similarity to already approved devices rather than presenting novel performance data.
§ 890.5740 Powered heating pad.
(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.