FDA 510(k)

Patch-TEA (型號 TRI-21)

K 號：K243613 · 2025-04-09

決定日期2025-04-09

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

Patch-TEA (Model TRI-21) is the device name listed in this FDA 510(k) record. The listed applicant is Transtimulation Research, Inc.. It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K243613. 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 Patch-TEA (Model TRI-21)?

Patch-TEA (Model TRI-21) is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Transtimulation Research, Inc.. The 510(k) number is K243613.

When did Patch-TEA (Model TRI-21) receive FDA 510(k) clearance?

Patch-TEA (Model TRI-21) received FDA 510(k) clearance on 2025-04-09, under 510(k) number K243613.

Who is the listed applicant for Patch-TEA (Model TRI-21)?

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

What is the FDA product code for Patch-TEA (Model TRI-21)?

The FDA product code for Patch-TEA (Model TRI-21) is NUH.

其他以 Transtimulation Research, 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。

K230526TEA設備

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。