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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 a medical device manufactured by Umeheal , Ltd.. It received FDA 510(k) clearance on 2019-12-23 under approval 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. It is manufactured by Umeheal , Ltd.. The 510(k) number is K192733.

When was RelieforMe TENS/EMS Device Model UPK-GE01 approved by the FDA?

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

What company makes RelieforMe TENS/EMS Device Model UPK-GE01?

RelieforMe TENS/EMS Device Model UPK-GE01 is manufactured by Umeheal , Ltd..

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.

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Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023) PMID: 36103178 Estimated Cost of Developing a Therapeutic Complex Medical Device in the US. JAMA network open (2022)

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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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