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510(k) Data Aggregation
K Number
K091993Device Name
RAPID PROGRAMMER, VERSION 3.3.0
Manufacturer
ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.)
Date Cleared
2009-07-31
(29 days)
Product Code
GZB
Regulation Number
882.5880Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
Device Description
The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
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