赫利奧兒童；阿佩克斯P
K 號：K260295 · 2026-05-28
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器材摘要
Helio Kids; Apex P is the device name listed in this FDA 510(k) record. The listed applicant is Motion Composites. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K260295. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Helio Kids; Apex P?
Helio Kids; Apex P is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Motion Composites. The 510(k) number is K260295.
When did Helio Kids; Apex P receive FDA 510(k) clearance?
Helio Kids; Apex P received FDA 510(k) clearance on 2026-05-28, under 510(k) number K260295.
Who is the listed applicant for Helio Kids; Apex P?
The FDA 510(k) record lists Motion Composites as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Helio Kids; Apex P?
The FDA product code for Helio Kids; Apex P is IOR.
相關臨床試驗
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其他以 Motion Composites 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。
相關器械（代碼：IOR）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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