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FDA 510(k)

Well-Life Garment Electrodes (GM Series)

K-Number: K200942 · 2021-06-01

ApplicantWell-Life Healthcare Limited
Decision Date2021-06-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Well-Life Garment Electrodes (GM Series) is a medical device manufactured by Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2021-06-01 under approval number K200942. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Well-Life Garment Electrodes (GM Series)?

Well-Life Garment Electrodes (GM Series) is a medical device that received FDA 510(k) clearance on 2021-06-01. It is manufactured by Well-Life Healthcare Limited. The 510(k) number is K200942.

When was Well-Life Garment Electrodes (GM Series) approved by the FDA?

Well-Life Garment Electrodes (GM Series) received FDA 510(k) clearance on 2021-06-01, under approval number K200942.

What company makes Well-Life Garment Electrodes (GM Series)?

Well-Life Garment Electrodes (GM Series) is manufactured by Well-Life Healthcare Limited.

What is the FDA product code for Well-Life Garment Electrodes (GM Series)?

The FDA product code for Well-Life Garment Electrodes (GM Series) is GXY.

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Other Devices by Well-Life Healthcare Limited

K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A K172809OTC Combo TENS/EMS System K162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A K222528Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode K220524Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) K213091Well-Life TENS/EMS/Heating Stimulator

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Related Devices (Code: GXY)

K161282FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2WMedico Electrodes International , Ltd. K160081TENS ElectrodesCathay Manufacturing Corp. K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesBio Protech, Inc. K152815Mailuokang Self-adhesive ElectrodeShenzhen Mailuokang Technology Co., Ltd. K152648Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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