Magstim Rapid2, Magstim Super Rapid2, Models 3004-000, 3005-00
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051864 FDA 510(k)
- FDA Product Code
- GWF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1870 FDA 510(k)
- Regulation Number
- 882.1870 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an electrical evoked response stimulator used for the stimulation of peripheral nerves. It is capable of delivering single pulses and repetitive stimulation with high power and frequency capabilities, serving as a diagnostic tool in neurology.
The device is supplied by The Magstim Company, Ltd. and is intended for use in clinical settings under the supervision of qualified medical professionals. It operates as a single-user system and requires the use of Magstim-manufactured accessories to ensure performance and safety. The device is regulated under FDA 510(k) clearance with the product code GWF and is classified as a Class II medical device.
Frequently asked questions
What is the MAGSTIM RAPID2 used for?
It is an electrical evoked response stimulator designed for peripheral nerve stimulation. It serves as a diagnostic tool in neurology by delivering single pulses and repetitive stimulation with high power and frequency capabilities.
How is the device supplied?
The device is supplied by The Magstim Company, Ltd. It is intended for use in clinical settings under the supervision of qualified medical professionals and operates as a single-user system.
What accessories are required?
The device requires the use of Magstim-manufactured accessories to ensure performance and safety. This requirement helps maintain consistent operation and prevents compatibility issues.
What are the model numbers included?
The device includes models 3004-000 and 3005-00. These models are part of the MAGSTIM RAPID2 and MAGSTIM SUPER RAPID2 series.
What is the regulatory classification?
The device is regulated under FDA 510(k) clearance with the product code GWF. It is classified as a Class II medical device, indicating it requires specific regulatory oversight for safety and effectiveness.
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: MAGSTIM RAPID2 OPERATING MANUAL Pdf Download | ManualsLib, Super Rapid² - Magstim, Magstim Rapid2, Magstim Super Rapid2, Models 3004-000, 3005-00 (K051864 ..., PDF Magstim Rapid2 Operating Manual - nmod-wiki.fcbg.ch, Magstim-Rapid2 - www.Cephalon.eu
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051864 | Class II | Active |
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Manufacturer
- Manufacturer
- The Magstim Company , Ltd.
Sources (1)
- FDA 510(k) K051864 24 fields · synced Oct 6, 2026