FDA 510(k)

iBOT® PMD

K 號：K243442 · 2025-01-30

決定日期2025-01-30

產品代碼IMK

諮詢委員會PM

決定相當於

器材摘要

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 2025-01-30 under 510(k) number K243442. 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® PMD?

iBOT® PMD is a medical device that received FDA 510(k) clearance on 2025-01-30. The listed applicant is Mobius Mobility. The 510(k) number is K243442.

When did iBOT® PMD receive FDA 510(k) clearance?

iBOT® PMD received FDA 510(k) clearance on 2025-01-30, under 510(k) number K243442.

Who is the listed applicant for 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® PMD?

The FDA product code for 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。

K210920iBOT個人移動裝置（iBOT 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。

K210920iBOT個人移動裝置（iBOT PMD）Mobius Mobility K172601下一代iBOTDeka Research & Development Corp.

官方來源

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