(128 days)
Relieve pain and itching, as an aid in the healing process of inflamed and traumatized tissue, and serve as a settting for removal of contamined tissue.
Not Found
This document is a 510(k) premarket notification acceptance letter from the FDA for a device called "Equinoxe Spa Tub." It declares the device substantially equivalent to a legally marketed predicate device.
The letter does not contain information about specific acceptance criteria, device performance, or any studies conducted. It focuses on regulatory approval based on substantial equivalence. Therefore, I cannot provide the requested table or answer the study-related questions based on this document.
§ 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.