FDA 510(k)

曼娜體育

K 號：K210284 · 2022-04-26

決定日期2022-04-26

產品代碼IMI

諮詢委員會PM

決定相當於

器材摘要

ManaSport is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, Inc.. It received FDA 510(k) clearance on 2022-04-26 under 510(k) number K210284. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ManaSport?

ManaSport is a medical device that received FDA 510(k) clearance on 2022-04-26. The listed applicant is Manamed, Inc.. The 510(k) number is K210284.

When did ManaSport receive FDA 510(k) clearance?

ManaSport received FDA 510(k) clearance on 2022-04-26, under 510(k) number K210284.

Who is the listed applicant for ManaSport?

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

What is the FDA product code for ManaSport?

The FDA product code for ManaSport is IMI.

其他以 Manamed, 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。

K231569ManaFlexx 2（型號：MF002-RX、MF002-OTC）K222098ManaSport+K211253電子波 K200353曼纳流 K200351血漿飛行 K160318血液流動設備

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相關器械（代碼：IMI）

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。

K240788超音波刺激器Jkh Health Co., Ltd.K230472聲波脉冲 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto K160378BRH-A2 雙重超音波與電場刺激 (CUSEFS) 設備Brh Medical , Ltd.K161628JAS Pulse™ 超音波治療器Bonutti Research, Inc.

官方來源

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