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FDA 510(k)

RelieforMe TENS/EMS Device Model UPK-GE01

K-Number: K192733 · 2019-12-23

ApplicantUmeheal , Ltd.
Decision Date2019-12-23
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RelieforMe TENS/EMS Device Model UPK-GE01 is the device name listed in this FDA 510(k) record. The listed applicant is Umeheal , Ltd.. It received FDA 510(k) clearance on 2019-12-23 under 510(k) number K192733. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RelieforMe TENS/EMS Device Model UPK-GE01?

RelieforMe TENS/EMS Device Model UPK-GE01 is a medical device that received FDA 510(k) clearance on 2019-12-23. The listed applicant is Umeheal , Ltd.. The 510(k) number is K192733.

When did RelieforMe TENS/EMS Device Model UPK-GE01 receive FDA 510(k) clearance?

RelieforMe TENS/EMS Device Model UPK-GE01 received FDA 510(k) clearance on 2019-12-23, under 510(k) number K192733.

Who is the listed applicant for RelieforMe TENS/EMS Device Model UPK-GE01?

The FDA 510(k) record lists Umeheal , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RelieforMe TENS/EMS Device Model UPK-GE01?

The FDA product code for RelieforMe TENS/EMS Device Model UPK-GE01 is IPF.

Related Devices (Code: IPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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