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…

Registry build 21.09.26

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.

3manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (1), Shanghai (1), Guangdong (1).

Chinese manufacturers registered for FDA product code QKC
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

Regulatory record for Vertigenius
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

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 numbers for Vertigenius
Catalogue number Size Status
VG01 In distribution
2 In distribution
2.2.0 Withdrawn

Same Product Code

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Product Sold by Catalogue numbers
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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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer