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FDA 510(k)

MyCRO Band

K-Number: K213587 · 2022-06-09

ApplicantOtto Bock Healthcare LP
Decision Date2022-06-09
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MyCRO Band is a medical device manufactured by Otto Bock Healthcare LP. It received FDA 510(k) clearance on 2022-06-09 under approval 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. It is manufactured by Otto Bock Healthcare LP. The 510(k) number is K213587.

When was MyCRO Band approved by the FDA?

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

What company makes MyCRO Band?

MyCRO Band is manufactured by Otto Bock Healthcare LP.

What is the FDA product code for MyCRO Band?

The FDA product code for MyCRO Band is MVA.

Other Devices by Otto Bock Healthcare LP

K201426MyCRO Band

Related Devices (Code: MVA)

K180568KidCapEastern Cranial Affiliates, LLC K193383SnugKapHeadstart, Ltd. K201426MyCRO BandOtto Bock Healthcare LP K220681Talee, Talee PostOPInvent Medical USA, LLC K203134Hanger Cranial Band 3DSymbion Logistics, LLC K230444Talee, Talee PostOpInvent Medical USA, LLC

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.

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