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FDA 510(k)

WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A

K-Number: K161453 · 2016-12-05

ApplicantWell-Life Healthcare Limited
Decision Date2016-12-05
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A is a medical device manufactured by Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2016-12-05 under approval number K161453. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A?

WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A is a medical device that received FDA 510(k) clearance on 2016-12-05. It is manufactured by Well-Life Healthcare Limited. The 510(k) number is K161453.

When was WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A approved by the FDA?

WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A received FDA 510(k) clearance on 2016-12-05, under approval number K161453.

What company makes WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A?

WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A is manufactured by Well-Life Healthcare Limited.

What is the FDA product code for WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A?

The FDA product code for WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A is NUH.

Related Clinical Trials

NCT04534556 Wireless Nerve Stimulation Device To Enhance Recovery After Stroke ENROLLING_BY_INVITATION

Other Devices by Well-Life Healthcare Limited

K172809OTC Combo TENS/EMS System K162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A 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

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Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd. K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. K151995Painmaster MCT PatchNewmark, Inc. K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc. K160893HANAROCare ReJuM.I.Tech 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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