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FDA 510(k)

Everyway Analog OTC TENS

K-Number: K222488 · 2022-11-15

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2022-11-15
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Everyway Analog OTC TENS is a medical device manufactured by Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2022-11-15 under approval number K222488. 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 Everyway Analog OTC TENS?

Everyway Analog OTC TENS is a medical device that received FDA 510(k) clearance on 2022-11-15. It is manufactured by Everyway Medical Instruments Co.,Ltd. The 510(k) number is K222488.

When was Everyway Analog OTC TENS approved by the FDA?

Everyway Analog OTC TENS received FDA 510(k) clearance on 2022-11-15, under approval number K222488.

What company makes Everyway Analog OTC TENS?

Everyway Analog OTC TENS is manufactured by Everyway Medical Instruments Co.,Ltd.

What is the FDA product code for Everyway Analog OTC TENS?

The FDA product code for Everyway Analog OTC TENS is NUH.

Other Devices by Everyway Medical Instruments Co.,Ltd

K182767V2 OTC Pain Relief TENS K182753A6 OTC Pain Relief TENS K181707Everyway Wireless TENS & EMS Unit K172919EV-804 OTC Pain Relief TENS K173186S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D K192589Everyway OTC TENS/EMS Combination

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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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