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FDA 510(k)

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4

K-Number: K251856 · 2025-11-21

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2025-11-21
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 is a medical device manufactured by Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2025-11-21 under approval number K251856. 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 Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4?

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Everyway Medical Instruments Co.,Ltd. The 510(k) number is K251856.

When was Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 approved by the FDA?

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 received FDA 510(k) clearance on 2025-11-21, under approval number K251856.

What company makes Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4?

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 is manufactured by Everyway Medical Instruments Co.,Ltd.

What is the FDA product code for Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4?

The FDA product code for Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 is NUH.

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Other Devices by Everyway Medical Instruments Co.,Ltd

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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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