AccessGUDID - DEVICE: Modius Sleep (05070002841203)

GUDID

Device Identifier (DI) Information

Brand Name: Modius Sleep
Version or Model: MS1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEUROVALENS LIMITED

Primary DI Number: 05070002841203
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 219363473 *Terms of Use

Device Description: Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia in adults. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS). It consists of a battery-powered device designed to deliver low-level electrical energy to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads that placed on the skin behind each ear.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
QJQ	Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230826	000

Device Exempt from Premarket Submission: No 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: 884a5d2e-0b46-49e3-be62-e5c1d80a4a74
Public Version Date: February 04, 2025
Public Version Number: 2
DI Record Publish Date: January 23, 2025