Cleared Traditional

K192733 - RelieforMe TENS/EMS Device Model UPK-GE01

K192733 is the FDA 510(k) clearance for RelieforMe TENS/EMS Device Model UPK-GE01 by Umeheal , Ltd.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K192733 · Umeheal , Ltd. · Physical Medicine device
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Dec 2019
Decision
87d
Days
Class 2
Risk

K192733 is an FDA 510(k) clearance for the RelieforMe TENS/EMS Device Model UPK-GE01. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Umeheal , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 23, 2019 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Umeheal , Ltd. devices

Submission Details

510(k) Number K192733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date December 23, 2019
Days to Decision 87 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Emergo Global Consulting, LLC
Randy Jiang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 134
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K192733.
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