FDA 510(k)

WELL LIFE Rx 无线经皮神经电刺激/电肌肉刺激器，型号 WR-2603/2603A，WR-2604/2604A 和 WR-2605/2605A

K号: K162663 · 2017-01-17

决定日期2017-01-17

产品代码GZJ

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决定实质等同

器械摘要

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.

常见问题

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.

列明Well-Life Healthcare Limited为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233054Well-Life 疼痛缓解（月经加）电刺激器；带月经缓解刺激器的TENS/EMS；Well-Life 疼痛缓解刺激器；月经加刺激器 K222528Well-Life 刺激/EMG 探头电极（型号：SA），Well-Life 尿失禁刺激/EMG 电极探头，Well-Life 探头电极 K220524Well-Life迷你经皮神经电刺激器（WL-23XXC/WL-23XXE系列）K213091健康生活经皮神经电刺激/电肌肉刺激/加热刺激器 K200942Well-Life服装电极（GM系列）K172809OTC 组合经皮神经电刺激/电肌肉刺激系统

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官方来源

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