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The Softique™ Paraffin Bath is an over-the-counter device intended for the following uses:

1. Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation
2. Relaxes muscles, relieves stiffness and muscle spasm
3. Stimulates circulation and for other conditions where heat is indicated

The Softique™ Paraffin Bath is a full-size paraffin bath with a paraffin wax capacity of five pounds (with a recommended use of three to four pounds of paratin wax), a melting time for the paraffin wax of approximately five hours, and a temperature range for the paraffin wax of 123-130°F. The unit utilizes two heaters with a total of 90 W in order to melt and maintain the temperature of the melted paraffin wax. The unit has an operation voltage of 120 V, 60 Hz. The Softique™ Paraffin Bath is supplied with a power cord, a plastic lid, three pounds of pure, hypo-allergenic paraffin wax, and 60 plastic liners.

This section is not applicable. The provided text is a 510(k) summary for a medical device (Softique™ Paraffin Bath) seeking substantial equivalence to predicate devices, not an AI/ML device that requires performance criteria based on a study. The document focuses on comparing the intended use, technological characteristics, and operating principles of the new device to existing ones rather than presenting a study to prove acceptance criteria through quantitative performance metrics.

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