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FDA 510(k)

快速重啟壓縮治療系統

K 號:K182668 · 2018-12-14

決定日期2018-12-14
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Rapid Reboot Compression Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Reboot Recovery Products, LLC. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182668. 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 Rapid Reboot Compression Therapy System?

Rapid Reboot Compression Therapy System is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Rapid Reboot Recovery Products, LLC. The 510(k) number is K182668.

When did Rapid Reboot Compression Therapy System receive FDA 510(k) clearance?

Rapid Reboot Compression Therapy System received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182668.

Who is the listed applicant for Rapid Reboot Compression Therapy System?

The FDA 510(k) record lists Rapid Reboot Recovery Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid Reboot Compression Therapy System?

The FDA product code for Rapid Reboot Compression Therapy System is IRP.

相關臨床試驗

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其他以 Rapid Reboot Recovery Products, 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。

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。

官方來源

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