RelieforMe TENS/EMS Device Model UPK-GE01— 510(k) K192733

Name: FDA 510(k) clearance K192733
Creator: U.S. Food and Drug Administration
Published: 2019-12-23

Substantially Equivalent

Umeheal , Ltd.

FDA 510(k) clearance K192733 for RelieforMe TENS/EMS Device Model UPK-GE01, Substantially Equivalent on 2019-12-23. Applicant: Umeheal , Ltd.. Device class: 2.

Clearance details

Applicant: Umeheal , Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2019-09-27
Decision date: 2019-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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