Cleared Traditional

K152571 - Stivax (FDA 510(k) Clearance)

K152571 · Biegler GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
260d
Days
-
Risk

K152571 is an FDA 510(k) clearance for the Stivax. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Biegler GmbH (Mauerbach, AT). The FDA issued a Cleared decision on May 26, 2016 after a review of 260 days - an extended review cycle.

This device falls under the Neurology FDA review panel. 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 Biegler GmbH devices

Submission Details

510(k) Number K152571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2015
Decision Date May 26, 2016
Days to Decision 260 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
112d slower than avg
Panel avg: 148d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Peers - BWK Stimulator, Electro-acupuncture

All 22
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K152571.
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Needle Stimulator (Model: RJNS6-1)
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Needle Stimulator
K202861 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2021
AXUS ES-5 Electro-Acupuncture Device
K200636 · Lhasa Oms, Inc. · Feb 2021