(85 days)
The Softique™ Paraffin Bath is an over-the-counter device intended for the following uses:
- Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation
- Relaxes muscles, relieves stiffness and muscle spasm
- 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.
§ 890.5110 Paraffin bath.
(a)
Identification. A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) and maintained at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.