FDA 510(k)

MyCRO Band

K-Number: K213587 · 2022-06-09

Decision Date2022-06-09

Product CodeMVA

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MyCRO Band is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Healthcare LP. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K213587. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MyCRO Band?

MyCRO Band is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Otto Bock Healthcare LP. The 510(k) number is K213587.

When did MyCRO Band receive FDA 510(k) clearance?

MyCRO Band received FDA 510(k) clearance on 2022-06-09, under 510(k) number K213587.

Who is the listed applicant for MyCRO Band?

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

What is the FDA product code for MyCRO Band?

The FDA product code for MyCRO Band is MVA.

Other records listing Otto Bock Healthcare LP as applicant

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.

K201426MyCRO Band

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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.