Cleared Traditional

K152571 - Stivax

K152571 · Biegler GmbH · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K152571

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 149d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Consultant

Promedic, Inc.
PAUL DRYDEN

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 - BWK Stimulator, Electro-acupuncture

All 18
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K152571.
Needle Stimulator
K202861 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2021
AXUS ES-5 Electro-Acupuncture Device
K200636 · Lhasa Oms, Inc. · Feb 2021
ANSiStim-PP
K170391 · Dyansys, Inc. · Mar 2017
ANSISTIM
K141168 · Dyansys, Inc. · May 2015
PANTHEON ELECTROSTIMULATOR
K133980 · Pantheon Research · Nov 2014
Electro Auricular Device
K140530 · Navigant Consulting, Inc. · Oct 2014
K152571 · Stivax
Download PDF FDA Summary Biegler GmbH