Devices · Otto Bock Healthcare Products GmbH

Myo Plus

Otto Bock Healthcare Products GmbH is listed for Myo Plus (K191179). The FDA list gives September 4, 2019 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is GXY. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191179

Official FDA database record

Date of final decision

September 4, 2019

Company on the FDA list

Otto Bock Healthcare Products GmbH

Lead panel

Neurology

Primary product code

GXY

openFDA device name for the code

Electrode, Cutaneous

Device class

2

Regulation number

882.1320

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary