(83 days)
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.
Luxury Paraffin Bath
The provided text is a 510(k) premarket notification letter from the FDA regarding a paraffin bath device. It does not contain any information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested table and details. The document is solely a regulatory approval letter.
§ 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.