(106 days)
The Reclin-A-Bath 2 is indicated for use with patients to relieve pain and itching. The Reclin-A-Bath 2 is indicated for use with patients to aid in the healing process of inflamed and traumatized tissue. The Reclin-A-Bath 2 is indicated for use with patients to serve as a setting for the removal of contaminated tissue.
Not Found
This document is an FDA 510(k) clearance letter for the Ferno Healthcare Recline-A-Bath 2. It indicates that the device has been deemed substantially equivalent to devices marketed prior to May 28, 1976.
Based on the provided text, there is no information available about acceptance criteria, the study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter focuses on the regulatory clearance process, stating that the device is substantially equivalent and can therefore be marketed. It does not contain the detailed technical or clinical study data that would address the questions posed.
Therefore, I cannot provide the requested table and information based on the input text.
§ 890.5100 Immersion hydrobath.
(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.