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FDA 510(k)

健康生活疼痛緩解（月經加強版）電刺激器；TENS/EMS 內含月經緩解刺激器；健康生活疼痛緩解刺激器；月經加強版刺激器

K 號：K233054 · 2024-10-18

申請人Well-Life Healthcare Limited
決定日期2024-10-18
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

Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K233054. 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 Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator?

Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K233054.

When did Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator receive FDA 510(k) clearance?

Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator received FDA 510(k) clearance on 2024-10-18, under 510(k) number K233054.

Who is the listed applicant for Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator?

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

What is the FDA product code for Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator?

The FDA product code for Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator is NUH.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Well-Life Healthcare 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。

K222528Well-Life 激發/EMG 探針電極 (型號：SA)，Well-Life 尿失禁激發/EMG 電極探針，Well-Life 探針電極K220524Well-Life Mini TENS刺激器（WL-23XXC/WL-23XXE系列）K213091健康生活 TENS/EMS/加熱刺激器K200942健康生活衣著電極（GM系列）K172809OTC 雙效電擊療/電肌肉刺激系統K162663WELL LIFE Rx 遥控式 TENS/EMS 刺激器，型號 WR-2603/2603A、WR-2604/2604A 及 WR-2605/2605A

查看所有 8 項裝置 →

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.,LtdK260412TENS 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

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