Neurovalens

GUDID 05070002841203

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.

NEUROVALENS LIMITED

Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system

• Primary Device ID: 05070002841203
• NIH Device Record Key: 884a5d2e-0b46-49e3-be62-e5c1d80a4a74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neurovalens
• Version Model Number: MS1000
• Company DUNS: 219363473
• Company Name: NEUROVALENS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05070002841203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230826

FDA Product Code

• QJQ: Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-31
• Device Publish Date: 2025-01-23

Devices Manufactured by NEUROVALENS LIMITED

• 05070002841210 - Modius Calm: 2025-04-14 Modius Calm is a non-invasive, home-use neurostimulation device that is indicated to treat Generalized Anxiety Disorder (GAD)
• 05070002841203 - Neurovalens: 2025-01-31Modius 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.
• 05070002841203 - Neurovalens: 2025-01-31 Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia in adults. The devi