Cleared Traditional

K131917 - NEURODYN COMPACT, NEURODYN II (FDA 510(k) Clearance)

K131917 · Ibramed Equipamentos Medicos · Physical Medicine device

Apr 2014

Decision

307d

Days

Class 2

Risk

K131917 is an FDA 510(k) clearance for the NEURODYN COMPACT, NEURODYN II. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Ibramed Equipamentos Medicos (Aventura, US). The FDA issued a Cleared decision on April 29, 2014, 307 days after receiving the submission on June 26, 2013.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K131917 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 26, 2013
Decision Date	April 29, 2014
Days to Decision	307 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF