Myo Plus
K-Number: K191179 · 2019-09-04
ApplicantOtto Bock Healthcare Products GmbH
Decision Date2019-09-04
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Myo Plus is a medical device manufactured by Otto Bock Healthcare Products GmbH. It received FDA 510(k) clearance on 2019-09-04 under approval number K191179. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Myo Plus?
Myo Plus is a medical device that received FDA 510(k) clearance on 2019-09-04. It is manufactured by Otto Bock Healthcare Products GmbH. The 510(k) number is K191179.
When was Myo Plus approved by the FDA?
Myo Plus received FDA 510(k) clearance on 2019-09-04, under approval number K191179.
What company makes Myo Plus?
Myo Plus is manufactured by Otto Bock Healthcare Products GmbH.
What is the FDA product code for Myo Plus?
The FDA product code for Myo Plus is GXY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.