CIONIC 62000004

GUDID G345620000040

Gait-enhancement electrical stimulation system, external

Primary Device ID	G345620000040
NIH Device Record Key	6d36cad4-b014-4894-8137-8beef1fbb95f
Commercial Distribution Status	In Commercial Distribution
Brand Name	CIONIC
Version Model Number	10
Catalog Number	62000004
Company DUNS	081351601
Company Name	Cionic, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	G345620000040 [Primary]

GZI	Stimulator, Neuromuscular, External Functional

Steralize Prior To Use	false
Device Is Sterile	false

G345620000040	CIONIC Android Gateway App
G345620000030	CIONIC iOS Gateway App
G345SL1000	Cionic Neural Sleeve NS-100 - Sleeve
G345DC1000	Cionic Neural Sleeve NS-100 - Control Unit