Cleared Traditional

Stivax

K152571 · Biegler GmbH · Neurology

May 2016

Decision

260d

Days

—

Risk

About This 510(k) Submission

K152571 is an FDA 510(k) clearance for the Stivax, a Stimulator, Electro-acupuncture, submitted by Biegler GmbH (Mauerbach, AT). The FDA issued a Cleared decision on May 26, 2016, 260 days after receiving the submission on September 9, 2015. This device falls under the Neurology review panel.

Submission Details

510(k) Number	K152571 FDA.gov
FDA Decision	Cleared 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