Cleared Traditional

K171397 - Sienna Ultimate Wireless Amplifier

K171397 is an FDA 510(k) clearance for Sienna Ultimate Wireless Amplifier, manufactured by Ems Handels Gesellschaft M.B.H.. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K171397 · Ems Handels Gesellschaft M.B.H. · Neurology device
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Oct 2017
Decision
148d
Days
Class 2
Risk

K171397 is an FDA 510(k) clearance for the Sienna Ultimate Wireless Amplifier. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Ems Handels Gesellschaft M.B.H. (Korneuburg, AT). The FDA issued a Cleared decision on October 6, 2017 after a review of 148 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ems Handels Gesellschaft M.B.H. devices

FDA 510(k) Submission Details - K171397

510(k) Number K171397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2017
Decision Date October 06, 2017
Days to Decision 148 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 148d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 19
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K171397.
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K870794 · Nihon Kohden America, Inc. · Sep 1987