FDA 510(k)

Y207 電動輪椅

K 號：K202482 · 2021-03-18

申請人Jiangsu Intco Medical Products Co., Ltd.

決定日期2021-03-18

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Y207 Electric Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Intco Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-18 under 510(k) number K202482. 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 Y207 Electric Wheelchair?

Y207 Electric Wheelchair is a medical device that received FDA 510(k) clearance on 2021-03-18. The listed applicant is Jiangsu Intco Medical Products Co., Ltd.. The 510(k) number is K202482.

When did Y207 Electric Wheelchair receive FDA 510(k) clearance?

Y207 Electric Wheelchair received FDA 510(k) clearance on 2021-03-18, under 510(k) number K202482.

Who is the listed applicant for Y207 Electric Wheelchair?

The FDA 510(k) record lists Jiangsu Intco Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Y207 Electric Wheelchair?

The FDA product code for Y207 Electric Wheelchair is ITI.

其他以 Jiangsu Intco Medical Products Co., Ltd. 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。

K253257薇若移動輪椅（薇若-D，薇若-F）K253241電動輪椅 (Y207BL)

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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