CES-Ultra CES-Ultra

GUDID M750AR635A0

Cranial Electrotherapy Stimulator

NEURO-FITNESS LLC

Psychiatric-therapy periauricular nerve transcutaneous electrical stimulator
Primary Device IDM750AR635A0
NIH Device Record Keyd0fd2eae-ed99-4d24-ac2b-68bcb7702936
Commercial Distribution StatusIn Commercial Distribution
Brand NameCES-Ultra
Version Model NumberAR635A
Catalog NumberCES-Ultra
Company DUNS078513618
Company NameNEURO-FITNESS LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com
Phone866-937-4237
Emailinfo@cesultra.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM750AR635A0 [Primary]

FDA Product Code

JXKStimulator, Cranial Electrotherapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-05
Device Publish Date2017-06-30

On-Brand Devices [CES-Ultra]

M750AR635A0Cranial Electrotherapy Stimulator
M750AR635ACranial Electrotherapy Stimulator

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.