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FDA 510(k)

Well-Life TENS/EMS/Heating Stimulator

K-Number: K213091 · 2022-02-19

ApplicantWell-Life Healthcare Limited
Decision Date2022-02-19
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Well-Life TENS/EMS/Heating Stimulator is a medical device manufactured by Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2022-02-19 under approval number K213091. 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 TENS/EMS/Heating Stimulator?

Well-Life TENS/EMS/Heating Stimulator is a medical device that received FDA 510(k) clearance on 2022-02-19. It is manufactured by Well-Life Healthcare Limited. The 510(k) number is K213091.

When was Well-Life TENS/EMS/Heating Stimulator approved by the FDA?

Well-Life TENS/EMS/Heating Stimulator received FDA 510(k) clearance on 2022-02-19, under approval number K213091.

What company makes Well-Life TENS/EMS/Heating Stimulator?

Well-Life TENS/EMS/Heating Stimulator is manufactured by Well-Life Healthcare Limited.

What is the FDA product code for Well-Life TENS/EMS/Heating Stimulator?

The FDA product code for Well-Life TENS/EMS/Heating Stimulator is NUH.

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 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)

View all 8 devices →

Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited 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.

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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