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FDA 510(k)

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

K-Number: K163166 · 2017-08-11

ApplicantEasywell Biomedicals, Inc.
Decision Date2017-08-11
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only is a medical device manufactured by Easywell Biomedicals, Inc.. It received FDA 510(k) clearance on 2017-08-11 under approval number K163166. 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 EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only?

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only is a medical device that received FDA 510(k) clearance on 2017-08-11. It is manufactured by Easywell Biomedicals, Inc.. The 510(k) number is K163166.

When was EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only approved by the FDA?

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only received FDA 510(k) clearance on 2017-08-11, under approval number K163166.

What company makes EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only?

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only is manufactured by Easywell Biomedicals, Inc..

What is the FDA product code for EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only?

The FDA product code for EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only is NUH.

Other Devices by Easywell Biomedicals, Inc.

K162509Infrared Non-contact Thermometer, Model ACT8100

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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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