(166 days)
Use wherever applications of heat, massage, or both 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 DC 9V current supplied through a standard adapter. 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 an electric heating pad (Health o meter, Model EHP4). It describes the device, its intended use, and claims substantial equivalence to previously cleared devices.
Crucially, this document does not describe any clinical study or provide performance data to establish specific acceptance criteria or to demonstrate that the device meets those criteria with respect to efficacy for its intended use (relief of minor muscular or joint pain).
The claim of substantial equivalence is based on the manufacturing technology, operating principles, intended uses, and safety standards being the same as predicate devices. The document explicitly states that "Functional differences, i.e. massage action, do not adversely affect safety or efficacy. Other differences are cosmetic in nature." This implies that the safety and efficacy are inferred from the predicate devices, rather than demonstrated through a new study for the EHP4.
Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about study design, sample sizes, expert involvement, or ground truth, as none of that information is present in the provided text.
If this were a typical AI/ML medical device submission, the provided information would be insufficient. For such devices, detailed performance metrics (like sensitivity, specificity, AUC) against established ground truth from a robust study would be expected.
§ 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.