Cleared Abbreviated

K060374 - REFA, PHYSIOLOGICAL AMPLIFIER

K060374 is an FDA 510(k) clearance for REFA, manufactured by Tms International BV. The device is a Class 2 Neurology device with product code GWL cleared through the Abbreviated 510(k) pathway after a 106-day FDA review.

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.

FDA 510(k) Submission Details - K060374

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 149d · This submission: 106d
Pathway characteristics
Standards-based clearance path.

GWL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GWL Amplifier, Physiological Signal

All 51
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K060374.
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G.USBAMP
K060803 · G.Tec Medical Engineering GmbH · May 2006
BE PLUS / AURA-LTM64 AMPLIFIER
K053606 · Eb Neuro S.P.A. · Jan 2006
SINGLE AMPLIFIER FOR BOTOX
K051852 · Allergan, Inc. · Sep 2005
K060374 · REFA, PHYSIOLOGICAL AMPLIFIER
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