FDA 510(k)

Revitive醫療教練（型號編號 5575AQ）

K 號：K210825 · 2021-12-17

決定日期2021-12-17

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Revitive Medic Coach (Model Number 5575AQ) is the device name listed in this FDA 510(k) record. The listed applicant is Actegy , Ltd.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K210825. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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. The listed applicant is Actegy , Ltd.. The 510(k) number is K210825.

When did Revitive Medic Coach (Model Number 5575AQ) receive FDA 510(k) clearance?

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

Who is the listed applicant for Revitive Medic Coach (Model Number 5575AQ)?

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 Coach (Model Number 5575AQ)?

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

其他以 Actegy , Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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

相關器械（代碼：NGX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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