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FDA 510(k)

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

K-Number: K162663 · 2017-01-17

ApplicantWell-Life Healthcare Limited
Decision Date2017-01-17
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A is a medical device manufactured by Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2017-01-17 under approval number K162663. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Well-Life Healthcare Limited. The 510(k) number is K162663.

When was WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A approved by the FDA?

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 approval number K162663.

What company makes 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 manufactured by Well-Life Healthcare Limited.

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.

Other Devices by Well-Life Healthcare Limited

K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A K172809OTC Combo TENS/EMS System K200942Well-Life Garment Electrodes (GM Series) 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

View all 8 devices →

Related Devices (Code: GZJ)

K160246SimulCare II(TM)Xanacare Technologies, LLC K153704StriveDjo, LLC K152676FD TENS 2090, FD TENS 2095Fuji Dynamics , Ltd. K173233ReliefBand 1.5Reliefband Technologies K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. K180943BioWaveGOBiowave Corporation

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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