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510(k) Data Aggregation
K Number
K031862Device Name
SPINERX-LDM
Manufacturer
SPINERX TECHNOLOGY
Date Cleared
2003-10-31
(137 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
SPINERX TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpineRx - LDM, Lumbar Decompression Machine, is intended to provide a variety of treatment options for patients who suffer from some of the most common forms of low back pain. Conditions which may be treated include bulging or protruding discs, herniated discs, degenerative disc disease, posterior facet syndrome and sciatica. The SpineRx - LDM can apply therapeutic decompression (distraction) force to relieve pressure on structures which may produce pain. Decompression can relieve pain by introducing a distraction force (unloading) sufficient to reduce intradiscal pressure and impingement. Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions. Variable angle positioning in either supine or prone modalities acts to concentrate decompression forces for optimum results. This machine is a prescription device and as such, it should be used under the direct supervision of a qualified medical professional.
Device Description
The SpineRx - LDM (lumbar decompression machine) combines proven characteristics of several predicate devices. The SpineRx - LDM provides variable angle decompression (distraction) in either prone or supine modality. The broad range of patient positioning variables allows either straight-line (linear) or angled (curvilinear) decompression (distraction) to be concentrated in more specific spinal segments. The harness and restraint system allows safe, effective application of therapeutic traction. The SpineRx - LDM traction device allows a wide range of selectable functions, force levels and time cycles. Prescribed treatment parameters are selected for each patient and each treatment session.
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