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510(k) Data Aggregation
K Number
K130249Device Name
INTEGRITY SPINAL CARE SYSTEM 3.0
Manufacturer
INTEGRITY LIFE SCIENCES
Date Cleared
2014-02-06
(370 days)
Product Code
ITH, INT
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
INTEGRITY LIFE SCIENCES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Integrity Spinal Care System 3.0 provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica.
Device Description
The Integrity Spinal Care System 3.0 incorporates the same principles and working characteristics of the predicate devices, the DRX9000 True Non Surgical Decompression System (K060735) and is same in size, shape and function. The components of The Integrity Spinal Care System 3.0 are substantially equivalent in form, fit, function and configuration to its predicate device the DRX9000 True Non Surgical Decompression System (K060735).There are similar key design technical characteristics; multi-function table designed to applied distraction forces and controlled by a computer console, same/similar components for treatment and measurement; similar size, power source, and performance.
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