FDA 510(k)RecoveryAir PRO
K 號:K211745 · 2021-10-04
決定日期2021-10-04
產品代碼IRP
諮詢委員會PM
決定相當於
器材摘要
RecoveryAir PRO is the device name listed in this FDA 510(k) record. The listed applicant is Theragun, Inc.. It received FDA 510(k) clearance on 2021-10-04 under 510(k) number K211745. 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 RecoveryAir PRO?
RecoveryAir PRO is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Theragun, Inc.. The 510(k) number is K211745.
When did RecoveryAir PRO receive FDA 510(k) clearance?
RecoveryAir PRO received FDA 510(k) clearance on 2021-10-04, under 510(k) number K211745.
Who is the listed applicant for RecoveryAir PRO?
The FDA 510(k) record lists Theragun, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RecoveryAir PRO?
The FDA product code for RecoveryAir PRO is IRP.
相關臨床試驗
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其他以 Theragun, Inc. 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。
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