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FDA 510(k)

Fist Assist 裝置型號 FA-1

K 號：K210281 · 2021-06-17

申請人Fist Assist Devices, LLC
決定日期2021-06-17
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Fist Assist Devices Model FA-1 is the device name listed in this FDA 510(k) record. The listed applicant is Fist Assist Devices, LLC. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K210281. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fist Assist Devices Model FA-1?

Fist Assist Devices Model FA-1 is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Fist Assist Devices, LLC. The 510(k) number is K210281.

When did Fist Assist Devices Model FA-1 receive FDA 510(k) clearance?

Fist Assist Devices Model FA-1 received FDA 510(k) clearance on 2021-06-17, under 510(k) number K210281.

Who is the listed applicant for Fist Assist Devices Model FA-1?

The FDA 510(k) record lists Fist Assist Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fist Assist Devices Model FA-1?

The FDA product code for Fist Assist Devices Model FA-1 is IRP.

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