FDA 510(k)

オートフォールディングスクーター、S21F

K番号: K220227 · 2022-10-12

決定日2022-10-12

製品コードINI

諮問委員会PM

決定Substantially Equivalent

医療機器の概要

Auto Folding Scooter, S21F is the device name listed in this FDA 510(k) record. The listed applicant is Heartway Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K220227. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Auto Folding Scooter, S21F?

Auto Folding Scooter, S21F is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Heartway Medical Products Co., Ltd.. The 510(k) number is K220227.

When did Auto Folding Scooter, S21F receive FDA 510(k) clearance?

Auto Folding Scooter, S21F received FDA 510(k) clearance on 2022-10-12, under 510(k) number K220227.

Who is the listed applicant for Auto Folding Scooter, S21F?

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

What is the FDA product code for Auto Folding Scooter, S21F?

The FDA product code for Auto Folding Scooter, S21F is INI.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

オートフォールディングスクーター、S21F

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：INI）

公式ソース