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CES-Ultra

FDA UDI

Class III (US FDA UDI)

by Neuro-Fitness Llc

Identity

Trade Name
CES-Ultra FDA UDI
Generic Name
Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system FDA UDI
Device Name
Cranial Electrotherapy Stimulator FDA UDI
Model / Reference
AR635A FDA UDI
Description
Cranial Electrotherapy Stimulator FDA UDI

Identifiers

Catalog Number
CES-Ultra FDA UDI
Primary DI / UDI-DI
M750AR635A0 FDA UDI
FDA Product Code
JXK FDA UDI
GMDN Term
Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
882.5800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system

CES-Ultra by Neuro-Fitness Llc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neuro-Fitness Llc

Sources (1)

  • FDA UDI d0fd2eae-ed99-4d24-ac2b-68bcb7702936 35 fields · synced May 30, 2026