(112 days)
For use in temporary symptomatic relief of minor pain due to medically diagnosed arthritis and bursitis.
Relaxes muscles, aids in the relief of stiff muscles, muscle spasms; helps to stimulate circulation.
Paramed Paraffin Warmer
This document is a 510(k) clearance letter from the FDA for a device called "Paramed Paraffin Warmer." It is not a study report and therefore does not contain information about acceptance criteria, device performance, study methodology, or ground truth establishment.
The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general control provisions.
To answer your request, a different type of document, such as a "Premarket Approval (PMA) application," a "De Novo classification request," or a "clinical study report," would be needed. This document only confirms the regulatory clearance based on substantial equivalence.
§ 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.