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510(k) Data Aggregation
K Number
K063353Device Name
CTBOX CERVICAL/LUMBAR TRACTION
Manufacturer
CIRCULAR TRACTION SUPPLY, INC.
Date Cleared
2007-03-14
(128 days)
Product Code
ITH, ILZ, IRS
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
CIRCULAR TRACTION SUPPLY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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