電動輪椅（Rollz Motion Electric 2M）
K 號：K250819 · 2025-11-07
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器材摘要
Electric Wheelchair (Rollz Motion Electric 2M) is the device name listed in this FDA 510(k) record. The listed applicant is Rollz International BV. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K250819. 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 Electric Wheelchair (Rollz Motion Electric 2M)?
Electric Wheelchair (Rollz Motion Electric 2M) is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Rollz International BV. The 510(k) number is K250819.
When did Electric Wheelchair (Rollz Motion Electric 2M) receive FDA 510(k) clearance?
Electric Wheelchair (Rollz Motion Electric 2M) received FDA 510(k) clearance on 2025-11-07, under 510(k) number K250819.
Who is the listed applicant for Electric Wheelchair (Rollz Motion Electric 2M)?
The FDA 510(k) record lists Rollz International BV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electric Wheelchair (Rollz Motion Electric 2M)?
The FDA product code for Electric Wheelchair (Rollz Motion Electric 2M) is ITI.
相關臨床試驗
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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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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