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K Number
K000852

Validate with FDA (Live)

Device Name
RENEW NEUROSTIMULATION SYSTEM
Manufacturer
ADVANCED NEUROMODULATION SYSTEMS
Date Cleared
2001-01-19

(310 days)

Product Code
GZF
Regulation Number
882.5870
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K141399,K150517,K152178,K243678
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.5870 Implanted peripheral nerve stimulator for pain relief.

(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).