Vertigenius VGHS01

GUDID 05391548420036

The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.

DIGITAL REHABILITATION LIMITED

Biomechanical function analysis/rehabilitation software

• Primary Device ID: 05391548420036
• NIH Device Record Key: 47ed0c8a-fddb-48a9-b180-966a414519b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertigenius
• Version Model Number: VG01
• Catalog Number: VGHS01
• Company DUNS: 985784463
• Company Name: DIGITAL REHABILITATION LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	05391548420029 [Primary]
GS1	05391548420036 [Package]; Contains: 05391548420029; Package: Unit Packaging - Box [1 Units]; In Commercial Distribution
GS1	05391548420043 [Package]; Contains: 05391548420029; Package: Shelf Carton [12 Units]; In Commercial Distribution

FDA Product Code

• QKC: Interactive Rehabilitation Exercise Device, Prescription Use

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: 2025-02-28
• Device Publish Date: 2025-02-20

On-Brand Devices [Vertigenius]

• 05391548420036: The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exe
• 05391548420012: The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exe
• 05391548420005: The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exe