Integrity V500 (Integrity, Integrity with VEMP)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242954 FDA 510(k)
- FDA Product Code
- GWJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1900 FDA 510(k)
- Regulation Number
- 882.1900 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Integrity V500 is an auditory evoked response stimulator designed to measure electrical activity in the auditory pathway. It delivers controlled auditory stimuli to assess vestibular-evoked myogenic potentials (VEMP) and other auditory responses, aiding in the evaluation of vestibular and cochlear function for neurological assessment.
This device is intended for use in clinical settings by trained professionals, typically in neurology departments. Supplied as a reusable medical instrument, it requires proper calibration and maintenance to ensure accurate measurements. The Integrity V500 holds FDA 510K clearance and MDR authorization, adhering to regulatory standards for auditory stimulators under classification II. Storage and handling follow manufacturer guidelines to preserve functionality and sterility.
Frequently asked questions
What clinical specialties primarily use the Integrity V500, and why is it relevant to them?
The Integrity V500 is primarily used in neurology departments, as it measures electrical activity in the auditory pathway to assess vestibular-evoked myogenic potentials (VEMP) and other auditory responses. This helps clinicians evaluate vestibular and cochlear function, which is critical for diagnosing and managing neurological conditions related to balance, hearing, and inner ear disorders.
Is the Integrity V500 a single-use or reusable device, and what maintenance does it require?
The Integrity V500 is a reusable medical instrument, meaning it is designed for repeated use in clinical settings. To ensure accurate measurements, it requires proper calibration and maintenance as outlined by the manufacturer. This includes regular servicing to preserve functionality and compliance with regulatory standards.
What regulatory pathways has the Integrity V500 followed, and what does this mean for its use?
The Integrity V500 has obtained FDA 510K clearance and MDR (Medical Device Regulation) authorization, confirming it meets regulatory standards for auditory stimulators under classification II. This means it has undergone rigorous evaluation to ensure safety, performance, and compliance with global medical device regulations, allowing its use in clinical settings where such approvals are recognized.
How is the Integrity V500 supplied, and are there different models or configurations available?
The Integrity V500 is supplied as a reusable device, with two primary configurations: the standard Integrity V500 and the Integrity V500 with VEMP capability. The VEMP version is specifically designed to measure vestibular-evoked myogenic potentials, offering additional functionality for assessing vestibular function alongside general auditory responses.
What storage and handling guidelines should be followed to maintain the Integrity V500’s functionality and sterility?
While the device itself is reusable and not sterile by design, the manufacturer provides guidelines for storage and handling to preserve its functionality and ensure proper operation. These guidelines likely include environmental controls (e.g., temperature, humidity), protection from physical damage, and adherence to cleaning protocols to prevent contamination or degradation of performance over time.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242954 | Class II | Active |
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Manufacturer
- Manufacturer
- Vivosonic Inc
- FDA Applicant
- Vivosonic, Inc.
Sources (2)
- FDA 510(k) K242954 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026