(231 days)
to aid in adding moisture to necrotic areas in order to aid in the debridement of wounds, to aid in the relief of pain and discomfort, to aid in the cleansing of open wounds, and as a form of physical therapy for certain types of pathologies.
The Banks Hydro-Therapy Chair provides whirlpool therapy in the home so that patients do not require unnecessary hospitalization or require transportation to a hospital. The Banks Hydro-Chair comprises: a chair for supporting the patient, the chair may comprise a backrest, armrest, seat and frame; a hydro-pad, suction cups for removably fastening the chair to a bath tub, the lateral stability of the chair may be increased by a Stable Bar that is removably fastened to the backrest and a corresponding side wall of the bath in which the whirlpool therapy is taking place. The Hydropad is connected at the base of the Chair and the posterior opening of the Hydro-pad connects to a hose(typically rubberized tubing)) which is connected to a blower motor which exerts a powerful pressure of air circulating through the ports of the Hydro-pad. Streams of water jet through the ports causing a swirling motion of the water in which the Hydro-pad is immersed. The Chair is also composed of a seat portion and the Chair is open so jets of water can reach the sacral, coccyx, rectum, groin and vaginal areas of the patient utilizing the Hydro-Therapy Chair. The seating and backing of the Chair are made of soft polyethylene material to prevent undue pressure to the skin during therapy. For handicapped and disabled persons, the arm frames of the Chair are easily removable.
This 510(k) summary for the Banks Hydro-Therapy Chair does not include any information about acceptance criteria or a study proving the device meets them.
The document explicitly states:
"Pursuant to 809.92(b)(1)-(3), applicant believes no assessment of performance data is necessary."
Therefore, I cannot provide the requested information. The device's submission to the FDA was based on substantial equivalence to a predicate device (Ferno-Washington, Inc. "Ferno-Ille-Hi-Lo, Jr.™") without the need for new performance data.
§ 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.