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K 號：K201645 · 2020-09-15
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器材摘要
Massage Compression Boots is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2020-09-15 under 510(k) number K201645. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Massage Compression Boots?
Massage Compression Boots is a medical device that received FDA 510(k) clearance on 2020-09-15. The listed applicant is Jkh USA, LLC. The 510(k) number is K201645.
When did Massage Compression Boots receive FDA 510(k) clearance?
Massage Compression Boots received FDA 510(k) clearance on 2020-09-15, under 510(k) number K201645.
Who is the listed applicant for Massage Compression Boots?
The FDA 510(k) record lists Jkh USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Massage Compression Boots?
The FDA product code for Massage Compression Boots is IRP.
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其他以 Jkh USA, LLC 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：IRP）
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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