FDA 510(k)

iSyncWave

K-Number: K220056 · 2022-08-10

Decision Date2022-08-10

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

iSyncWave is the device name listed in this FDA 510(k) record. The listed applicant is iMediSync, Inc.. It received FDA 510(k) clearance on 2022-08-10 under 510(k) 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. The listed applicant is iMediSync, Inc.. The 510(k) number is K220056.

When did iSyncWave receive FDA 510(k) clearance?

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

Who is the listed applicant for iSyncWave?

The FDA 510(k) record lists iMediSync, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iSyncWave?

The FDA product code for iSyncWave is GWQ.

Other records listing iMediSync, Inc. 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.

Related Devices (Code: GWQ)

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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.