FDA 510(k)

geko™ T-2 及 geko™ Plus R-2 神經肌肉刺激器

K 號：K163125 · 2017-04-10

決定日期2017-04-10

產品代碼IPF

諮詢委員會PM

決定相當於

器材摘要

geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2017-04-10 under 510(k) number K163125. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators?

geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Firstkind Limited. The 510(k) number is K163125.

When did geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators receive FDA 510(k) clearance?

geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators received FDA 510(k) clearance on 2017-04-10, under 510(k) number K163125.

Who is the listed applicant for geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators?

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

What is the FDA product code for geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators?

The FDA product code for geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators is IPF.

其他以 Firstkind Limited 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。

K220327geko W-3 K212762geko W-2 K201131火飛蟲 T-2 K193045geko™ W-2 K191113geko T-2 及 geko T-3 神經肌肉刺激器 K181059geko T-3 神經肌肉刺激器

查看所有 8 項裝置 →

相關器械（代碼：IPF）

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。

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816高頻功率治療法（HiToP）（型號：HiToP PNP）Mohammadali Nezakati K260142StimelMD (SSMD) 系統Motion Informatics ltd.K251083精巧IIEnraf-Nonius, B.V.K241433EVE 統合（EVE-20M）Weero Co., Ltd.K241488TrainFES先進版Trainfes

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。