Cleared Traditional

TumEase Acupressure Bracelets (K193374) - FDA 510(k) Clearance

K193374 · Mumease · Neurology device
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Mar 2020
Decision
90d
Days
-
Risk

K193374 is an FDA 510(k) clearance for the TumEase Acupressure Bracelets. Classified as Device, Acupressure (product code MVV).

Submitted by Mumease (Charlotte, US). The FDA issued a Cleared decision on March 4, 2020 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mumease devices

Submission Details

510(k) Number K193374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2019
Decision Date March 04, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVV Device, Acupressure
Device Class -

Regulatory Consultant

Medavice, Inc.
Bill Jacqmein

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.