(148 days)
Bath for the bathing of disabled persons.
Not Found
This is a letter from the FDA to Medi-Man Rehabilitation Products, Inc. regarding their A-2000 Bathing Systems; Hydrosonic Bathing System (K992779). The letter states that the device has been reviewed and determined to be substantially equivalent to devices marketed prior to May 28, 1976. This allows Medi-Man Rehabilitation Products to market the device.
The document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. It is a regulatory approval letter based on "substantial equivalence" to a predicate device, not a performance study. Therefore, I cannot provide the requested information.
§ 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.