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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Healthcare Products GmbH. It received FDA 510(k) clearance on 2019-09-04 under 510(k) 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. The listed applicant is Otto Bock Healthcare Products GmbH. The 510(k) number is K191179.

When did Myo Plus receive FDA 510(k) clearance?

Myo Plus received FDA 510(k) clearance on 2019-09-04, under 510(k) number K191179.

Who is the listed applicant for Myo Plus?

The FDA 510(k) record lists Otto Bock Healthcare Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myo Plus?

The FDA product code for Myo Plus is GXY.

Other records listing Otto Bock Healthcare Products GmbH as applicant

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Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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