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FDA 510(k)

SIMPLYSTRONG, SIMPLYEZEE

K-Number: K181791 · 2018-08-21

ApplicantGenicon, Inc.
Decision Date2018-08-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SIMPLYSTRONG, SIMPLYEZEE is a medical device manufactured by Genicon, Inc.. It received FDA 510(k) clearance on 2018-08-21 under approval number K181791. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLYSTRONG, SIMPLYEZEE?

SIMPLYSTRONG, SIMPLYEZEE is a medical device that received FDA 510(k) clearance on 2018-08-21. It is manufactured by Genicon, Inc.. The 510(k) number is K181791.

When was SIMPLYSTRONG, SIMPLYEZEE approved by the FDA?

SIMPLYSTRONG, SIMPLYEZEE received FDA 510(k) clearance on 2018-08-21, under approval number K181791.

What company makes SIMPLYSTRONG, SIMPLYEZEE?

SIMPLYSTRONG, SIMPLYEZEE is manufactured by Genicon, Inc..

What is the FDA product code for SIMPLYSTRONG, SIMPLYEZEE?

The FDA product code for SIMPLYSTRONG, SIMPLYEZEE is GCJ.

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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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