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FDA 510(k)

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806

K-Number: K202317 · 2020-11-13

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2020-11-13
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 is a medical device manufactured by Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2020-11-13 under approval number K202317. 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, model EV-804, model EV-805, & model EV-806?

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 is a medical device that received FDA 510(k) clearance on 2020-11-13. It is manufactured by Everyway Medical Instruments Co.,Ltd. The 510(k) number is K202317.

When was Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 approved by the FDA?

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 received FDA 510(k) clearance on 2020-11-13, under approval number K202317.

What company makes Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806?

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 is manufactured by Everyway Medical Instruments Co.,Ltd.

What is the FDA product code for Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806?

The FDA product code for Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 is NUH.

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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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