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FDA 510(k)

小波弧；小波翻轉

K 號：K223533 · 2023-08-31

申請人Ki Mobility, LLC
決定日期2023-08-31
產品代碼LBE
諮詢委員會PM
決定相當於

器材摘要

Little Wave Arc; Little Wave Flip is the device name listed in this FDA 510(k) record. The listed applicant is Ki Mobility, LLC. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K223533. The device is classified under product code LBE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Little Wave Arc; Little Wave Flip?

Little Wave Arc; Little Wave Flip is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Ki Mobility, LLC. The 510(k) number is K223533.

When did Little Wave Arc; Little Wave Flip receive FDA 510(k) clearance?

Little Wave Arc; Little Wave Flip received FDA 510(k) clearance on 2023-08-31, under 510(k) number K223533.

Who is the listed applicant for Little Wave Arc; Little Wave Flip?

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

What is the FDA product code for Little Wave Arc; Little Wave Flip?

The FDA product code for Little Wave Arc; Little Wave Flip is LBE.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Ki Mobility, 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。

K200583Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTLK201869Ki Power 倾斜系統K223527小浪Clik，Rogue XP，小浪XP，Spark

官方來源

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