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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.

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Relaxation of muscle spasm.
Prevention of retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the MS300 and MS400 devices and does not contain information about acceptance criteria or a study proving that the devices meet them.

The document states that the FDA has determined the devices are substantially equivalent to devices marketed prior to May 28, 1976. This means the manufacturer did not have to submit new clinical study data to demonstrate safety and effectiveness if they could show substantial equivalence to an existing predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and the study details as it is not present in the provided text.

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• Relaxation of Muscle Spasm
• Prevention of Retardation of disuse atrophy.
• Increasing local blood circulation
• Muscle Re-education.
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
• Maintaining or increasing range of motion.

Not Found

The provided text is a 510(k) premarket notification approval letter from the FDA to LSI International for their devices MS300 and MS400. This document focuses on the regulatory aspects of device approval (substantial equivalence to predicate devices) and does not contain information about specific acceptance criteria, study methodologies, or performance data of the MS300 and MS400 devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as it is not present in the provided text.

Ask a specific question about this device

Ask a specific question about this device