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The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Description of Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp; Marvel Lamp and Wonder Lamp are used to provide topical heating to the body. The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp are specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,200 to 1,500 hours of usage. 110 volt power, 250 watts. It includes timer, safety fuses w/o remote control.

The provided text is a 510(k) Pre-Market Notification summary for an infrared heating lamp. It does not contain information about a study proving the device meets acceptance criteria.

Instead, it states:

(b)(1)(2)(3) Substantial equivalence is not based on an assessment of performance data.

This means that the device's approval for market (K081720) was based on its substantial equivalence to previously cleared predicate devices (K960036, K890556, K991503, K003528), rather than through a new study assessing specific performance metrics against pre-defined acceptance criteria. The document explicitly states that performance data was not used for this determination.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study, as such information is not present in the provided text.

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