(90 days)
The Quantum Intersegmental Roller Traction Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.
The Quantum Intersegmental Roller Traction Table features three six inch wide, six inch diameter rollers which rotate in a clockwise or counter-clockwise direction while tracking up and down the back. The roller height can be adjusted to place varying degrees of pressure on the muscles of the back while the patient is lying in the supine position.
This document is a 510(k) summary for the Quantum Intersegmental Roller Traction Table. It claims substantial equivalence to a predicate device and states the intended uses. However, it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. Therefore, I cannot provide the requested information.
§ 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).