Identifiers
- 510(k) Number
- K163150 FDA 510(k)
- FDA Product Code
- IKN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.1375 FDA 510(k)
- Regulation Number
- 890.1375 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ViMove2 is an electromyograph, diagnostic device used in physical medicine. It is a wearable sensor technology system that includes motion sensors and a software interface for assessment and monitoring.
The device is supplied as a system for clinical or outdoor use, supporting patient assessment, coaching, and out-of-clinic monitoring. It is authorized under FDA 510(k) clearance (K163150) and is classified as a Class II medical device.
Frequently asked questions
What is the ViMove2 device used for?
ViMove2 is an electromyograph diagnostic device used in physical medicine for patient assessment, coaching, and out-of-clinic monitoring. It combines wearable motion sensors with a software interface to evaluate and track neuromuscular function during clinical or outdoor activities.
How is the ViMove2 system supplied and what does it include?
ViMove2 is supplied as a complete system for clinical or outdoor use, comprising wearable sensor technology that includes motion sensors and a software interface. This setup enables assessment and monitoring of patient movement and muscle activity in various environments.
Is the ViMove2 device reusable or single-use?
ViMove2 is designed as a reusable system. The wearable sensors and software interface are intended for multiple uses in clinical or outdoor settings, supporting repeated patient assessments and monitoring sessions over time.
What regulatory pathway was used for ViMove2 authorization?
ViMove2 received authorization through the FDA 510(k) clearance process, specifically under submission K163150. It was determined to be substantially equivalent to a predicate device and is classified as a Class II medical device.
What type of medical device is ViMove2 classified as?
ViMove2 is classified as an electromyograph, diagnostic device under FDA regulations. It falls within the physical medicine specialty and is categorized as a Class II medical device based on its intended use and technological characteristics.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: System Documentation - dorsaVi, DORSAVI VIMOVE2 USER MANUAL Pdf Download | ManualsLib, ViMove2: Wearable Sensor Technology | Running Reborn, dorsaVi ViMove2 User Manual | Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163150 | Class II | Active |
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Manufacturer
- Manufacturer
- Dorsavi Ltd
- FDA Applicant
- Dorsavi, Ltd.
Sources (1)
- FDA 510(k) K163150 24 fields · synced Sep 21, 2026