FDA 510(k)

WELL LIFE Rx 遥控式 TENS/EMS 刺激器，型號 WR-2603/2603A、WR-2604/2604A 及 WR-2605/2605A

K 號：K162663 · 2017-01-17

決定日期2017-01-17

產品代碼GZJ

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 Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A 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 2017-01-17 under 510(k) number K162663. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A?

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A is a medical device that received FDA 510(k) clearance on 2017-01-17. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K162663.

When did WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A receive FDA 510(k) clearance?

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A received FDA 510(k) clearance on 2017-01-17, under 510(k) number K162663.

Who is the listed applicant for WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A?

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 Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A?

The FDA product code for WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A is GZJ.

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。

K233054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 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

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相關器械（代碼：GZJ）

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。

K252712STIMPOD NMS460 神經刺激器Algiamed Technologies USA, Inc.K252767actiTENS迷你版Sublimed K252236CP緩解棒Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046電氣神經肌肉刺激器，治療三合一Oriental Inspiration Limited

官方來源

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