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FDA 510(k)

Revitive Medic Coach (Model Number 5575AQ)

K-Number: K210825 · 2021-12-17

ApplicantActegy , Ltd.
Decision Date2021-12-17
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Revitive Medic Coach (Model Number 5575AQ) is a medical device manufactured by Actegy , Ltd.. It received FDA 510(k) clearance on 2021-12-17 under approval number K210825. 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 Coach (Model Number 5575AQ)?

Revitive Medic Coach (Model Number 5575AQ) is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Actegy , Ltd.. The 510(k) number is K210825.

When was Revitive Medic Coach (Model Number 5575AQ) approved by the FDA?

Revitive Medic Coach (Model Number 5575AQ) received FDA 510(k) clearance on 2021-12-17, under approval number K210825.

What company makes Revitive Medic Coach (Model Number 5575AQ)?

Revitive Medic Coach (Model Number 5575AQ) is manufactured by Actegy , Ltd..

What is the FDA product code for Revitive Medic Coach (Model Number 5575AQ)?

The FDA product code for Revitive Medic Coach (Model Number 5575AQ) is NGX.

Related Clinical Trials

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026)

Other Devices by Actegy , Ltd.

K152480Revitive Medic; Revitive MV; Revitive LV K190924Revitive Medic Plus, Revitive Advanced 2 K192887Revitive Medic Plus, Revitive Advanced 2

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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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