AccessGUDID - DEVICE: CES-Ultra (M750AR635A0)

GUDID

Device Identifier (DI) Information

Brand Name: CES-Ultra
Version or Model: AR635A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CES-Ultra
Company Name: NEURO-FITNESS LLC

Primary DI Number: M750AR635A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078513618 *Terms of Use

Device Description: Cranial Electrotherapy Stimulator

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61022	Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system	An assembly of portable, battery-powered devices designed to apply noninvasive cranial electrical stimulation (CES) via cranial/peripheral nerves in/around the external ear for the treatment of one or more psychiatric and stress-related disorders (e.g., anxiety, depression, insomnia, migraine); it might additionally be intended for the treatment of autoimmune diseases (e.g., rheumatoid arthritis). It consists of an external pulse generator (EPG) with controls/display, and transcutaneous electrodes for placement on the skin surface in/around the external ear. The device may be used in conjunction with a smartphone for use by a patient and healthcare provider. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXK	Stimulator, Cranial Electrotherapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d0fd2eae-ed99-4d24-ac2b-68bcb7702936
Public Version Date: November 23, 2021
Public Version Number: 4
DI Record Publish Date: June 30, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 866-937-4237
Email: info@cesultra.com

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