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510(k) Data Aggregation
K Number
K073542Device Name
CYCLETRAC CT-5000
Manufacturer
Date Cleared
2008-02-14
(59 days)
Product Code
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
PT PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CycleTrac® Automated Cervical Traction Unit provides a primary treatment modality for the management of neck and back pain. Intermittent/static cervical traction results in cervical disk decompression (unloading due to distraction and positioning) which provides relief of pain associated with a variety of conditions involving anatomical dysfunctions of the spine, including protruding or herniated intervertebral discs, degenerative discs and acute facet problems.
Device Description
The CycleTrac® CT-5000 Automated Cervical Traction Unit is a device intended to apply intermittent or static traction force to the patients' spine. Unlike other traction devices, the CycleTrac® CT-5000 attaches to a Standard 6 Foot Plinth or a 6 Foot Stationary Chiropractic Adjusting Table (not included). When the CycleTrac® CT-5000 is properly attached to the treatment table it is 26.6 inches long and stands 42 inches off the floor. The CycleTrac CT-5000 system has a total weight of 14.5 pounds. The traction force is generated by a non-powered, factory certified gas spring capable of generating up to 35 pounds of load. By adjusting the pivot point of the energized spring along the weight index bar, the traction pull force on the traction pull cord can range from 15 to 35 pounds. The engineering principle behind this change in force is the mechanical advantage created when the energized spring pivot point is adjusted along the weight index bar. As the pivot point moves further from the traction pull cord intercept, the force required to compress the energized spring decreases. As the energized spring pivot peint gets closer to the traction pull cord intercept, the mechanical advantage lessens and the force required to compress the energized spring increases. When the pivot point is next to the traction pull cord intercept. there is no mechanical advantage and the force required to compress the energized spring is equal to the maximum output of the energized spring. 35 pounds. The force required to compress the energized spring is equal to the push back force of the energized spring on the traction cord, or the traction pull force on the traction pull cord.
The motorized actuator pulls on the extension linkage attached to the weight index bar, which compresses the energized spring, parking it in the traction. To return to the traction ON position, the actuator is extended through the extension linkages attached to the weight index bar allowing the energized spring to freely extend, creating a force on the weight index bar. The force on the weight index bar is transferred to the traction pull cord placing the CT-5000 into the traction on position.
The ON-OFF intermittent cervical traction cycle is controlled by the timer. The traction treatment time, traction ON time, and the traction OFF time are pre-set on the timer. The settings are used by the timer to prompt the actuator to extend and retract, which results in the traction ON / traction OFF intermittent cervical traction cycle. Therefore, the timer and the motorized actuator do not contribute to the traction pull force on the patient. The traction pull force is generated solely by the NON POWERED, factory certified, 35 pound energized spring; the CT-5000 does not require power to generate the traction pull force.
The unique headrest design allows for 100% of the traction force toward the occiput without forehead and chin restrains and eliminates the possibility of Temporomandibular Joint problems. The headrest is made of powder coated aluminum and covered with a comfort pad to keep the patient comfortable.
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