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510(k) Data Aggregation
K Number
K200848Device Name
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
Manufacturer
Micron Medical Corporation
Date Cleared
2020-08-14
(136 days)
Product Code
GZF
Regulation Number
882.5870Why did this record match?
Applicant Name (Manufacturer) :
Micron Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Moventis PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Moventis PNS is not intended to treat pain in the craniofacial region.
Device Description
Moventis PNSTM is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain originating from peripheral nerves. The therapy utilizes pulsed electrical waveforms to create an electrical energy field that acts on afflicted peripheral nerves to alter the transmission of pain signals from those nerves to the brain. Moventis PNS is comprised of percutaneous Implanted Pulse Generator (pIPG) and a preprogrammed External Transmitter (ETx) worn outside the body over the general area of the pIPG to provide signal and power.
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