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FDA 510(k)

卡瑪驅動輪椅

K 號:K202506 · 2021-04-19

決定日期2021-04-19
產品代碼ITI
諮詢委員會PM
決定相當於

器材摘要

Karma Powered Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Karma Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-04-19 under 510(k) number K202506. 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 Karma Powered Wheelchair?

Karma Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2021-04-19. The listed applicant is Karma Medical Products Co., Ltd.. The 510(k) number is K202506.

When did Karma Powered Wheelchair receive FDA 510(k) clearance?

Karma Powered Wheelchair received FDA 510(k) clearance on 2021-04-19, under 510(k) number K202506.

Who is the listed applicant for Karma Powered Wheelchair?

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

What is the FDA product code for Karma Powered Wheelchair?

The FDA product code for Karma Powered Wheelchair 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。

官方來源

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