Identity
- Trade Name
- Vertigenius FDA UDI
- Generic Name
- Biomechanical function analysis/rehabilitation software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 2.2.0 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- VGCP01 FDA UDI
- Primary DI / UDI-DI
- 05391548420012 FDA UDI
- FDA Product Code
- QKC FDA UDI
- GMDN Term
- Biomechanical function analysis/rehabilitation software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Vertigenius by Digital Rehabilitation Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Digital Rehabilitation Limited
Sources (1)
- FDA UDI 54ac3e7d-aaa6-4dc3-aa74-e814da86969a 35 fields · synced May 30, 2026