Catalog Number

CES-Ultra

Brand Name

CES-Ultra

Version/Model Number

AR635A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JXK

Product Code Name

Stimulator, Cranial Electrotherapy

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

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-