FDA 510(k)

調頻自適應移動應用程式

K 號：K251208 · 2025-09-26

決定日期2025-09-26

產品代碼SCR

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

Tuned Self-Fitting Mobile App is the device name listed in this FDA 510(k) record. The listed applicant is Tuned , Ltd.. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K251208. The device is classified under product code SCR. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tuned Self-Fitting Mobile App?

Tuned Self-Fitting Mobile App is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Tuned , Ltd.. The 510(k) number is K251208.

When did Tuned Self-Fitting Mobile App receive FDA 510(k) clearance?

Tuned Self-Fitting Mobile App received FDA 510(k) clearance on 2025-09-26, under 510(k) number K251208.

Who is the listed applicant for Tuned Self-Fitting Mobile App?

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

What is the FDA product code for Tuned Self-Fitting Mobile App?

The FDA product code for Tuned Self-Fitting Mobile App is SCR.

其他以 Tuned , 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。

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相關器械（代碼：SCR）

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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