FDA 510(k)

Compex Wireless USA

K 號：K170903 · 2017-06-19

決定日期2017-06-19

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Compex Wireless USA is the device name listed in this FDA 510(k) record. The listed applicant is Djo, LLC. It received FDA 510(k) clearance on 2017-06-19 under 510(k) number K170903. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Compex Wireless USA?

Compex Wireless USA is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is Djo, LLC. The 510(k) number is K170903.

When did Compex Wireless USA receive FDA 510(k) clearance?

Compex Wireless USA received FDA 510(k) clearance on 2017-06-19, under 510(k) number K170903.

Who is the listed applicant for Compex Wireless USA?

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

What is the FDA product code for Compex Wireless USA?

The FDA product code for Compex Wireless USA is NGX.

其他以 Djo, LLC 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。

K201653Compex Sport Elite 3.0 K170918Compex運動精英 K153704努力 K153696查塔諾加革命無線 K153224VitalStim(R) Plus 電療系統

相關器械（代碼：NGX）

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。

K253790高強度聚焦電磁刺激器（FE60）Beijing Winkonlaser Technology Limited K253926迪阿科爾ShenB Co., Ltd.K253636Zionic Pro Max (電動肌肉刺激器)Termosalud S.L.K253408涼頻Zimmer Medizinsysteme GmbH K252154攜帶式電刺激治療設備（LGT-2320BE、LGT-2320ME 及 LGT-2320SP）Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ 腰部肌肉刺激器 (OT01-1003)Motive Health, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。