FDA 510(k)

PlasmaFlow X 腫瘤壓縮袖套設備 (XPF0001)

K 號：K251446 · 2025-09-17

決定日期2025-09-17

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

PlasmaFlow X Compression Sleeve Device (XPF0001) is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, LLC. It received FDA 510(k) clearance on 2025-09-17 under 510(k) number K251446. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PlasmaFlow X Compression Sleeve Device (XPF0001)?

PlasmaFlow X Compression Sleeve Device (XPF0001) is a medical device that received FDA 510(k) clearance on 2025-09-17. The listed applicant is Manamed, LLC. The 510(k) number is K251446.

When did PlasmaFlow X Compression Sleeve Device (XPF0001) receive FDA 510(k) clearance?

PlasmaFlow X Compression Sleeve Device (XPF0001) received FDA 510(k) clearance on 2025-09-17, under 510(k) number K251446.

Who is the listed applicant for PlasmaFlow X Compression Sleeve Device (XPF0001)?

FDA 510(k) 記錄將 Manamed, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for PlasmaFlow X Compression Sleeve Device (XPF0001)?

The FDA product code for PlasmaFlow X Compression Sleeve Device (XPF0001) is JOW.

其他以 Manamed, 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。

K260944瑪娜冷壓系統

相關器械（代碼：JOW）

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。

K261807連續循環器（SC-4004-DL，SC-4008-DL）Bio Compression Systems, Inc.K254217AerloomEvolym, LLC K253555Flexitouch® Plus 進階氣動壓迫系統Tactile Medical K253386DVT 裝備Vistar Medical Supplies Co., Ltd.K250242壓力治療設備（LGT-2202DVT）Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

官方來源

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