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FDA 510(k)

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)

K-Number: K201257 · 2021-04-06

ApplicantArrive Systems, Inc.
Decision Date2021-04-06
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is a medical device manufactured by Arrive Systems, Inc.. It received FDA 510(k) clearance on 2021-04-06 under approval number K201257. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)?

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is a medical device that received FDA 510(k) clearance on 2021-04-06. It is manufactured by Arrive Systems, Inc.. The 510(k) number is K201257.

When was MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) approved by the FDA?

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) received FDA 510(k) clearance on 2021-04-06, under approval number K201257.

What company makes MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)?

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is manufactured by Arrive Systems, Inc..

What is the FDA product code for MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)?

The FDA product code for MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is NGX.

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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.

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