FDA 510(k)

ENSO（型號2）

K 號：K233784 · 2024-02-23

決定日期2024-02-23

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

ENSO (Model 2) is the device name listed in this FDA 510(k) record. The listed applicant is Hinge Health, Inc.. It received FDA 510(k) clearance on 2024-02-23 under 510(k) number K233784. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ENSO (Model 2)?

ENSO (Model 2) is a medical device that received FDA 510(k) clearance on 2024-02-23. The listed applicant is Hinge Health, Inc.. The 510(k) number is K233784.

When did ENSO (Model 2) receive FDA 510(k) clearance?

ENSO (Model 2) received FDA 510(k) clearance on 2024-02-23, under 510(k) number K233784.

Who is the listed applicant for ENSO (Model 2)?

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

What is the FDA product code for ENSO (Model 2)?

The FDA product code for ENSO (Model 2) is NUH.

其他以 Hinge Health, Inc. 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。

K254216Enso 頭痛用藥品

相關器械（代碼：NUH）

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。

K261131電動肌肉刺激器（AST-105DJ、AST-105EJ、AST-105BJ、AST-105GJ、AST-303J、AST-309J、AST-310J；AST-300Q、AST-300Q-A、AST-500B；AST-500G、AST-500F；AST-500N；AST-500C、AST-500K、AST-500A；AST-300E、AST-500M、AST-500U、AST-500D；AST-500E。）Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 可充電 4 頻道 (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS 裝置（FT-247 系列產品）（FT-247，FT-237）Hivox Biotek, Inc.K253896TENS/EMS 裝置（GUSE01）Globalcare Medical Technology Co., Ltd.K253305電擊療與電肌肉刺激器（TENS 和 Muscle Stimulator）(JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited

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。