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FDA 510(k)

iSyncWave

K-Number: K220056 · 2022-08-10

ApplicantiMediSync, Inc.
Decision Date2022-08-10
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

iSyncWave is a medical device manufactured by iMediSync, Inc.. It received FDA 510(k) clearance on 2022-08-10 under approval number K220056. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iSyncWave?

iSyncWave is a medical device that received FDA 510(k) clearance on 2022-08-10. It is manufactured by iMediSync, Inc.. The 510(k) number is K220056.

When was iSyncWave approved by the FDA?

iSyncWave received FDA 510(k) clearance on 2022-08-10, under approval number K220056.

What company makes iSyncWave?

iSyncWave is manufactured by iMediSync, Inc..

What is the FDA product code for iSyncWave?

The FDA product code for iSyncWave is GWQ.

Other Devices by iMediSync, Inc.

K222838iSyncBrain©-C

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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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