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510(k) Data Aggregation
K Number
K951622Device Name
VAX-D THERAPEUTIC TABLE
Manufacturer
VAT-TECH, INC.
Date Cleared
1996-07-02
(488 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
VAT-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VAX-D® Therapeutic Table is designed to relieve pressure on structures that may be causing low back pain. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radicular pain. It achieves these effects through decompression of intervertebral discs, that is, unloading, due to distraction and positioning.
This therapy provides a primary treatment modality for the management of pain and disability for patients presenting with incapacitating low back pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the lumbar spine that generate localized low back pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs, degenerative discs as well as those with acute facet problems.
Device Description
The VAX-D® Therapeutic Table is designed to apply distraction tensions to the patient's lumbar spine. The patient lies on the table in a prone position; the upper body is on the stationary portion of the table and is restrained by the patient holding on to adjustable hand grips. The table is a split-table design, whereby distraction tensions are applied to the patient through a pelvic harness attached to a tensionometer and by the separation of the movable part of the table. The VAX-D® Therapeutic Table provides automated or varied timed distraction cycles. For safety, the patient holds on to the handgrip which can be released at any time to end the session and restore full relaxation. Distraction tensions and rates are continuously monitored and measured by the tensionometer attached to the pelvic belt, and the output is shown on a digital gauge and captured on a pen-writer printout, or optionally through direct connection to a computer terminal. The chart recording forms a permanent record of the treatment parameters, which becomes part of the patient's chart.
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