Cleared Traditional

K193374 - TumEase Acupressure Bracelets

K193374 · Mumease · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K193374

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.

MVV Device Classification - Class 0,

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.

Regulatory Peers - MVV Device, Acupressure

All 10
Devices cleared under the same product code (MVV) and FDA review panel - the closest regulatory comparables to K193374.
FridaMom Anti-Nausea Bands
K220289 · Fridababy, LLC · Jun 2022
Bonine Acupressure Bands
K211823 · Wellspring Pharmaceutical Corporation · Sep 2021
Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip
K142471 · Pressure Point, Inc. · Dec 2014
BARF BAND
K110821 · Doodlebug Products, LLC · Feb 2012
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP
K110563 · Therapeutics 101, Inc (Dba Pressure Point, Inc.) · Apr 2011
PSI BANDS
K070766 · Psi Health Solutions, Inc. · Jul 2007