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FDA 510(k)

Luggie 椅子

K 號：K160139 · 2017-03-20

申請人Freerider Corporation
決定日期2017-03-20
產品代碼ITI
諮詢委員會PM
決定相當於

器材摘要

Luggie Chair is the device name listed in this FDA 510(k) record. The listed applicant is Freerider Corporation. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K160139. 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 Luggie Chair?

Luggie Chair is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Freerider Corporation. The 510(k) number is K160139.

When did Luggie Chair receive FDA 510(k) clearance?

Luggie Chair received FDA 510(k) clearance on 2017-03-20, under 510(k) number K160139.

Who is the listed applicant for Luggie Chair?

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

What is the FDA product code for Luggie Chair?

The FDA product code for Luggie Chair is ITI.

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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

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