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510(k) Data Aggregation
K Number
K131983Device Name
ITRAC CERVICAL TRACTION SYSTEM
Manufacturer
PIVOTAL HEALTH SOLUTIONS
Date Cleared
2014-09-10
(439 days)
Product Code
ITH, ILZ, IRS
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
PIVOTAL HEALTH SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iTrac c2i cervical traction system is intended for use as a conservative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis extension and altered posture. It temporarily positions the cervical 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
The iTrac™ c2i cervical traction system is intended for use as a conservative treatment alternative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis/extension and altered posture. It temporarily positions the cervical 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.
Operational software controls the exertion and release of the pulling forces, operation cycle, and treatment times prescribed by the physician. The iTrac's operational components consist of software, an air compressor, three pneumatic cylinders, two electro-pneumatic regulators, a traction line and pullev system, head halter, fulcrum strap, magnetic safety release, backup flow controls, and mechanical pressure relief valves.
All accessories necessary to provide the traction to the patient are included with the device making it a ready to use traction device. A head halter captures the patient's chin during treatment and is connected to an adjustable overhead traction bar that can be manually adjusted by the doctor to the doctor-prescribed traction angle. A fulcrum strap rests on the back of the patient's neck and may be used to provide an additional anterior force. During setup, an electric lift column allows the fulcrum/traction section to be raised or lowered by the doctor to the height doctor prescribed for each patient.
For each treatment session the Doctor commands the software to implement a specific treatment time, traction force, and fulcrum force. Utilizing a piecewise linear function calculation the software generates an output signal causing the electro-pneumatic pressure controllers to adjust pressure, delivering the doctor prescribed forces to the fulcrum and traction cylinders. For safety, limits are hard coded in the software to prevent traction and fulcrum forces from exceeding the allowable limits. The software is loaded on a standard personal computer which interfaces with the device via a standard network connection; this standard connection is limited to connection only with the iTrac.
A Patient Stop Switch provides additional protection to the patient by operating independent of software to relieve all forces when pressed. When activated, the patient stop switch triggers a relay which, in turn, triggers a solenoid-controlled pneumatic valve causing a quick stop and venting of all pneumatic pressure to the cylinders. This action immediately relieves the patient of traction forces and sends a discrete output from the relay to the I/O Module, placing the treatment session into 'Pause' within the software. As an added safety measure the software requires the patient stop switch to be pressed before the start of each treatment during the treatment start protocol to ensure its functionality.
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K Number
K101889Device Name
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
Manufacturer
PIVOTAL HEALTH SOLUTIONS
Date Cleared
2010-08-27
(51 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
PIVOTAL HEALTH SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Decompression' of Choice (DOC) and AAAR 2K10 is a non invasive method of applying distractive forces to the spine through controlled tensions. It is designed to apply decompression (decompression is unloading due to distraction and positioning and/or as non-surgical in nature) forces to intervertebral discs. The Decompression' of Choice (DOC) and AAAR 2K10 may be used for back pain, neck pain, hemiated discs, protruding discs, degenerative disc disease, sciatica and posterior facet syndromes.
Device Description
The Devices are a non surgical traction or also called decompression' systems. It accurately controls tensions designed to relax Para spinal musculature and to allow distractive- traction forces to decompress inter vertebral spinal disk space. The Devices do this by creating a negative pressure in the disc due to the distractive forces and treatment protocols. Bulges or herniation are reduced back into the center or annular part of the disc. Fibroblasts then form a matrix over the protryded area to form a "seal" over the previously injured area. The load cell constantly updates the user interface provided which controls a gear-motor/linear actuator to immediately and safely apply forces as determined by qualified healthcare personnel. The load cell feedback is also used to further verify and adjust traction forces allowing for variations in patient postures and outside influencing forces. This method of operation allows safe, continuous and smooth operation of the unit and proper comfortable and safe appliance of said forces to the patient. An extensive manual of suggested treatment protocols and safety warnings is furnished to the end user.
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