CES-Ultra CES-Ultra

GUDID M750AR635A

Psychiatric-therapy periauricular nerve transcutaneous electrical stimulator

Primary Device ID	M750AR635A
NIH Device Record Key	6c0a8402-f90b-4a8c-a574-3807163fa833
Commercial Distribution Status	In Commercial Distribution
Brand Name	CES-Ultra
Version Model Number	AR635A
Catalog Number	CES-Ultra
Company DUNS	078513618
Company Name	NEURO-FITNESS LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	false
Serial Number	true
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	M750AR635A [Primary]

JXK	Stimulator, Cranial Electrotherapy

Steralize Prior To Use	false
Device Is Sterile	false

M750AR635A0	Cranial Electrotherapy Stimulator
M750AR635A	Cranial Electrotherapy Stimulator