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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 149d · 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 Consultant

Smith Associates
Yolanda Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWL Amplifier, Physiological Signal

All 43
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K171397.
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K133517 · Eb Neuro S.P.A. · Feb 2014
K171397 · Sienna Ultimate Wireless Amplifier
Download PDF FDA Summary Ems Handels Gesellsch…