(57 days)
To provide paraspinal treatment in the form of articulation pressure, heat, and vibration.
The P.T. Machine and the predicate devices are AC-powered physical therapy tables that consist of rollers-to-provide articulation pressure, a heat source to provide heat therapy, and a vibrational source to provide massage therapy. Moreover, all three devices are programmable devices that may be programmed either by the Chiropractor or the patient.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on Goodman's P.T. Machine. The document is a 510(k) summary for a physical therapy table, focusing on its substantial equivalence to predicate devices. It discusses similarities in intended use, principles of operation, and technological characteristics, and explicitly states that "The minor differences among the devices do not raise any new questions of safety or effectiveness."
Therefore, I cannot provide the requested information regarding acceptance criteria and studies.
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).