Home GUDID G345SL2000 CIONIC
Primary DI G345SL2000
Brand CIONIC
Company Cionic, Inc.
Model NS-200
Catalog number NS200
Device description Cionic Neural Sleeve NS-200
Published 2026-06-04
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GZI Stimulator, Neuromuscular, External Functional HCC Device, Biofeedback IPF Stimulator, Muscle, Powered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GZI Stimulator, Neuromuscular, External Functional Neurology 2 HCC Device, Biofeedback Neurology 2 IPF Stimulator, Muscle, Powered Physical Medicine 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G345SL2000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Gait-enhancement electrical stimulation system, external An assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 081351601 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes#