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FDA 510(k)

OTC Combo TENS/EMS System

K-Number: K172809 · 2017-10-18

ApplicantWell-Life Healthcare Limited
Decision Date2017-10-18
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OTC Combo TENS/EMS System is a medical device manufactured by Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2017-10-18 under approval number K172809. 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 OTC Combo TENS/EMS System?

OTC Combo TENS/EMS System is a medical device that received FDA 510(k) clearance on 2017-10-18. It is manufactured by Well-Life Healthcare Limited. The 510(k) number is K172809.

When was OTC Combo TENS/EMS System approved by the FDA?

OTC Combo TENS/EMS System received FDA 510(k) clearance on 2017-10-18, under approval number K172809.

What company makes OTC Combo TENS/EMS System?

OTC Combo TENS/EMS System is manufactured by Well-Life Healthcare Limited.

What is the FDA product code for OTC Combo TENS/EMS System?

The FDA product code for OTC Combo TENS/EMS System is NUH.

Other Devices by Well-Life Healthcare Limited

K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A 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

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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