FDA 510(k)

iBOT個人移動裝置（iBOT PMD）

K 號：K210920 · 2021-06-16

決定日期2021-06-16

產品代碼IMK

諮詢委員會PM

決定相當於

器材摘要

iBOT Personal Mobility Device (iBOT PMD) is the device name listed in this FDA 510(k) record. The listed applicant is Mobius Mobility. It received FDA 510(k) clearance on 2021-06-16 under 510(k) number K210920. The device is classified under product code IMK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iBOT Personal Mobility Device (iBOT PMD)?

iBOT Personal Mobility Device (iBOT PMD) is a medical device that received FDA 510(k) clearance on 2021-06-16. The listed applicant is Mobius Mobility. The 510(k) number is K210920.

When did iBOT Personal Mobility Device (iBOT PMD) receive FDA 510(k) clearance?

iBOT Personal Mobility Device (iBOT PMD) received FDA 510(k) clearance on 2021-06-16, under 510(k) number K210920.

Who is the listed applicant for iBOT Personal Mobility Device (iBOT PMD)?

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

What is the FDA product code for iBOT Personal Mobility Device (iBOT PMD)?

The FDA product code for iBOT Personal Mobility Device (iBOT PMD) is IMK.

其他以 Mobius Mobility 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。

K243442iBOT® PMD

相關器械（代碼：IMK）

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。

K243442iBOT® PMDMobius Mobility K172601下一代iBOTDeka Research & Development Corp.

官方來源

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