FDA 510(k)

Ki Power 倾斜系統

K 號：K201869 · 2023-09-05

決定日期2023-09-05

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Ki Power Tilt System 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 2023-09-05 under 510(k) number K201869. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ki Power Tilt System?

Ki Power Tilt System is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Ki Mobility, LLC. The 510(k) number is K201869.

When did Ki Power Tilt System receive FDA 510(k) clearance?

Ki Power Tilt System received FDA 510(k) clearance on 2023-09-05, under 510(k) number K201869.

Who is the listed applicant for Ki Power Tilt System?

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 Ki Power Tilt System?

The FDA product code for Ki Power Tilt System is ITI.

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 TTL K223533小波弧；小波翻轉 K223527小浪Clik，Rogue XP，小浪XP，Spark

相關器械（代碼：ITI）

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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官方來源

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