FDA 510(k)

APEX 手動輪椅

K 號：K161425 · 2016-12-05

決定日期2016-12-05

產品代碼IOR

諮詢委員會PM

決定相當於

器材摘要

APEX Manual Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Motion Composites. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K161425. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the APEX Manual Wheelchair?

APEX Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Motion Composites. The 510(k) number is K161425.

When did APEX Manual Wheelchair receive FDA 510(k) clearance?

APEX Manual Wheelchair received FDA 510(k) clearance on 2016-12-05, under 510(k) number K161425.

Who is the listed applicant for APEX Manual Wheelchair?

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

What is the FDA product code for APEX Manual Wheelchair?

The FDA product code for APEX Manual Wheelchair is IOR.

其他以 Motion Composites 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。

K260295赫利奧兒童；阿佩克斯P

相關器械（代碼：IOR）

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。

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbH K261919多功能輪椅（YJ-059）Zhenjiang Assure Medical Equipment Co., Ltd.K260144傾斜輪椅（YJ-013L）Zhenjiang Assure Medical Equipment Co., Ltd.K260141體重減輕重型輪椅 (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 轮椅 (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K261571手動輪椅（H008，PCK7）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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