Vertigenius
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…
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.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Sintang Health&Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 21 |
| Shanghai Zdroid Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Guangzhou Sowen Digital Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 1 |
Record
| Listed by | Digital Rehabilitation Limited |
|---|---|
| FDA product code | QKC |
| Device type | Interactive Rehabilitation Exercise Device, Prescription Use |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5360 |
| Premarket notification | Exempt |
| Record published | 2025-02-23 |
| Record revised | 2025-05-19 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Unit packaging – box, shelf carton of 12 |
| Distribution end date | 2025-02-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VG01 | In distribution | |
| 2 | In distribution | |
| 2.2.0 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kemtai Care | Kemtai | 5 |
| Reality DTx | Strolll, Inc. | 4 |
| MindMotion GO Procedure Pack | NeuroXtherapeutics SA | 2 |
| Bits FR | Bioness Medical, Inc. | 2 |
| Strolll Rehab | Strolll, Inc. | 1 |
| MindPod Dolphin | NeuroXtherapeutics SA | 1 |
| EverEx Rehab | Everex SRL | 1 |
| YourSteps | Yoursteps Health, Inc. | 1 |
| Exer Health | Exer Labs, Inc. | 1 |
| VSTBalance | Virtusense | 1 |
| Exer Physio | Exer Labs, Inc. | 1 |
| GaitSmart® | Dynamic Metrics Limited | 1 |
Showing 12 of 22. All products under Interactive Rehabilitation Exercise Device, Prescription Use
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.