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FDA 510(k)

Revitive Medic; Revitive MV; Revitive LV

K-Number: K152480 · 2016-03-31

ApplicantActegy , Ltd.
Decision Date2016-03-31
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Revitive Medic; Revitive MV; Revitive LV is the device name listed in this FDA 510(k) record. The listed applicant is Actegy , Ltd.. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K152480. 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 Revitive Medic; Revitive MV; Revitive LV?

Revitive Medic; Revitive MV; Revitive LV is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Actegy , Ltd.. The 510(k) number is K152480.

When did Revitive Medic; Revitive MV; Revitive LV receive FDA 510(k) clearance?

Revitive Medic; Revitive MV; Revitive LV received FDA 510(k) clearance on 2016-03-31, under 510(k) number K152480.

Who is the listed applicant for Revitive Medic; Revitive MV; Revitive LV?

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

What is the FDA product code for Revitive Medic; Revitive MV; Revitive LV?

The FDA product code for Revitive Medic; Revitive MV; Revitive LV is NGX.

Other records listing Actegy , Ltd. 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.

K210825Revitive Medic Coach (Model Number 5575AQ)K192887Revitive Medic Plus, Revitive Advanced 2K190924Revitive Medic Plus, Revitive Advanced 2

Related Devices (Code: NGX)

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.

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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.

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