Revitive Medic Coach (Model Number 5575AQ)— 510(k) K210825

Name: FDA 510(k) clearance K210825
Creator: U.S. Food and Drug Administration
Published: 2021-12-17

Substantially Equivalent

Actegy , Ltd.

FDA 510(k) clearance K210825 for Revitive Medic Coach (Model Number 5575AQ), Substantially Equivalent on 2021-12-17. Applicant: Actegy , Ltd.. Device class: 2.

Clearance details

Applicant: Actegy , Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2021-03-19
Decision date: 2021-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bracknell, GB

Download summary PDF View on FDA.gov ↗

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