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K Number
K992911
Device Name
MAGSTIM RAPID
Manufacturer
MAGSTIM CORPORATION US
Date Cleared
2000-01-07

(130 days)

Product Code
GWF
Regulation Number
882.1870
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Stimulation of peripheral nerves.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the Magstim Rapid device. It states that the device is substantially equivalent to legally marketed predicate devices for the indication of "Stimulation of peripheral nerves."

However, this document does not contain any information regarding acceptance criteria, device performance metrics, study designs (e.g., sample sizes, ground truth establishment, expert qualifications, or MRMC studies), or specific results of any performance studies.

Therefore, I cannot fulfill your request for the information outlined in your prompt using only the provided text. The document is an administrative clearance letter, not a technical report detailing performance assessment.

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).