(217 days)
Hydrotherapy - relieve pain and itching
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding the Hydrotone device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI-related metrics.
Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices for the indicated use of "Hydrotherapy - relieve pain and itching."
§ 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.