Cleared Abbreviated

REFA, PHYSIOLOGICAL AMPLIFIER (K060374) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K060374 · Tms International BV · Neurology device
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May 2006
Decision
106d
Days
Class 2
Risk

K060374 is an FDA 510(k) clearance for the REFA, PHYSIOLOGICAL AMPLIFIER. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Tms International BV (Evergreen, US). The FDA issued a Cleared decision on May 30, 2006 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Tms International BV devices

Submission Details

510(k) Number K060374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2006
Decision Date May 30, 2006
Days to Decision 106 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 148d · This submission: 106d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

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