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FDA 510(k)

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300

K-Number: K202470 · 2020-11-25

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2020-11-25
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 is a medical device manufactured by Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2020-11-25 under approval number K202470. 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 EM-6000, EM-6100, EM-6200 & EM-6300?

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by Everyway Medical Instruments Co.,Ltd. The 510(k) number is K202470.

When was Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 approved by the FDA?

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 received FDA 510(k) clearance on 2020-11-25, under approval number K202470.

What company makes Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300?

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 is manufactured by Everyway Medical Instruments Co.,Ltd.

What is the FDA product code for Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300?

The FDA product code for Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 is NUH.

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Other Devices by Everyway Medical Instruments Co.,Ltd

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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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