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510(k) K193374

Device
TumEase Acupressure Bracelets
Applicant
MumEase
510(k) number
K193374
Product code
MVV  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-04
Date received
2019-12-05
Regulation
510(k) Premarket Notification
Classification name
Device, Acupressure
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Neurology
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Catherine Varley
Address
227 W 4th St. Charlotte NC US 28202 28202

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MVV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220289FridaMom Anti-Nausea BandsFridababy, LLC2022-06-29
K211823Bonine Acupressure BandsWellspring Pharmaceutical Corporation2021-09-01
K142471Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist StripPressure Point, Inc.2014-12-01
K110821BARF BANDDoodlebug Products, LLC2012-02-27
K110563PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIPTherapeutics 101, Inc (Dba Pressure Point, Inc.)2011-04-08
K070766PSI BANDSPsi Health Solutions, Inc.2007-07-26
K053509ACUBAND ACUPRESSURE WRIST BAND DEVICEAcuband, Inc.2006-08-16
K051397BIOBANDSBiobands Distributors, Inc.2005-09-16
K041766EZY-TRAVEL WRISTBANDApothecary Products, Inc.2004-11-26
K041877ACU-STRAP MOTION SICKNESS BANDHealth Ent., Inc.2004-10-08
K033268SEA-BANDSea-Band UK , Ltd.2004-01-07
K900588ACU-BAND ACCUPRESSURE WRIST BANDEuro-Am Pharma, Inc.1990-02-22

Legacy Summary#

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FDA Review#

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