(128 days)
The "CT Box™" cervical/lumbar traction system is intended for use as a conservative treatment alternative in patients presenting with cervicogenic/lumbogenic pain symptoms of mechanical origin related to reduced cervical or lumbar lordosis/extension and altered posture. It temporarily positions the cervical or lumbar spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.
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This is a 510(k) clearance letter for a medical device called the "CTBox Cervical/Lumbar Traction System." This document primarily focuses on the regulatory clearance process and does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the way requested.
The provided text discusses the device's classification, regulation, and its "Indications For Use" but does not include the type of performance study details requested. Standard 510(k) submissions typically rely on demonstrating "substantial equivalence" to a predicate device rather than presenting extensive de novo performance studies with specific acceptance criteria and detailed study designs as would be expected for novel or high-risk devices.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document is a regulatory clearance letter, not a clinical study report.
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).