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510(k) Data Aggregation
K Number
K071347Device Name
VAX-D GENESIS G2 SYSTEM
Manufacturer
VAX-D MEDICAL TECHNOLOGIES LLC
Date Cleared
2007-10-05
(144 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
VAX-D MEDICAL TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VAX-D Genesis G2 Dynamic Logarithmic Spinal Decompression System is designed to relieve pressure on structures that may be causing low back pain, sciatica and neck pain. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radio. This is achieved non-surgically through the application of logarithmic distraction tensions applied to the patient according to the VAX-D protocol.
This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with spinal pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the spine that generate localized pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs as well as those with acute facet problems and sciatica.
Device Description
The VAX-D Genesis G2 is designed to apply distraction tensions to the patient's lumbar and cervical spine in order to non-surgically decompress the spine and intervertebral disc. Disc decompression is defined as unloading due to distraction and positioning. For lumbar treatment the patient is fitted with pelvic harness and lies on the table; the upper body is positioned on the stationary partion of the table and is restrained by the patient holding on to adjustable handgrips, or by the vise of possive shoulder restraint. The table is a split table design, whereby distraction tensions are applied to the patient through a harness attached to a tensionometer and by the separation of the movable part of the movable The tensionometer can be programmed to move synchronously in a horizontal rand vertical plane in order to apply tension in a logarithmic time/force progression that is designed to follow the curvature of the spine.
The system is designed to apply tensions to the spine in a smooth logarithmic time/force curve that allows trunk and paraspinal muscles to relax. The system provides automated or variable e ined distraction-relaxation cycles. For safety the patient holds on to handgrips which can be released at any time to end the session and restore full relaxation. The patient may choose to use a passive shoulder restraint that utilizes a patient 'quick release' buckle, or they may use the handheld patient safety witch to stop the treatment. For cervical treatment the tensionometer applies tension to the cervical spine through a cervical harness. Distraction tensions and rates are continuously monitored and measured hy the tensionometer, and the output is monitored by a computer system which continuously processes the data and adjusts the tension to produce a patented 'logarithmic' curve. The chart recording produced is a permanent record of the treatment parameters which becomes part of the patient's chart.
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