Model: AR635A
Catalog: CES-Ultra
DI: M750AR635A1
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2017-02-12
Current Version: 2026-05-22
Description
Cranial Electrotherapy Stimulator
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
5
Record Key:
6c0a8402-f90b-4a8c-a574-3807163fa833
Distribution Status:
In Commercial Distribution
DUNS Number:
078513618
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
M750AR635A1
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 61022
Name: Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Definition:
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.
FDA Product Codes
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Premarket Submissions
Submission Number:
K062284
Supplement Number:
000