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U.S. Department of Health and Human Services

Medical Devices

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Examples of MMAs the FDA Has Cleared or Approved

Following are some examples of mobile medical applications  the FDA has cleared since 1997.  The list is intended to show examples of mobile medical apps and does not include all the mobile medical apps we have cleared.  For more information about any of the apps below, please search the FDA 510(k) medical devices database by 510(k) number in the search field.

FDA Cleared Mobile Medical Applications
Last updated (June 6, 2013)

Device NameApplicant510(k) NumberDecision Date
RHYTHMSTAT XLDATA CRITICAL CORP.K97165012/04/1997
MOBILE-PATIENT VIEWERDATA CRITICAL CORPORATIONK01143607/05/2001
MODIFICATION TO: POCKETVIEW ECG SOFTWAREMICROMEDICAL INDUSTRIES, LTD.K01331101/03/2002
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEMABBOTT DIABETES CARE INC.K02086606/11/2002
TM2005 PERSONAL MEDICAL PHONE CENTERCARD GUARD SCIENTIFIC SURVIVAL, LTD.K02436501/15/2003
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARYSIGMA INTL.K04212108/26/2004
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDERNORTHEAST MONITORING, INC.K04190108/31/2004
AIRSTRIP OBMP4 SOLUTIONS, LPK04208201/21/2005
VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221WEISSBURG ASSOCIATESK05185709/15/2005
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWAREGE HEALTHCAREK05297501/20/2006
PILL PHONEVOCELK06029803/29/2006
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWAREGE HEALTHCAREK06199408/11/2006
CG-6108 ARRHYTHMIA ECG EVENT RECORDERCARD GUARD SCIENTIFIC SURVIVAL, LTD.K06091108/22/2006
IMCO-STATIMCO TECHNOLOGIESK06339212/12/2006
SILHOUETTE, MODEL 1000.01ARANZ MEDICAL LIMITEDK07042606/29/2007
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100MEDAPPS, INC.K06237707/03/2007
CUSTOMIZED SOUND THERAPY (CST)TINNITUS OTOSOUND PRODUCTS, LLCK07059907/13/2007
CONFIDANT 2.5CONFIDANT INC.K07269811/16/2007
AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZBAVITA CORPORATIONK07213712/07/2007
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL, LTD.K07199512/18/2007
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL, LTD.K08125705/29/2008
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMSENTRA HEALTH SYSTEMS, LTD.K08170301/08/2009
AIRSTRIP OBAIRSTRIP TECHNOLOGIES, LPK09006101/23/2009
AIRSTRIP OBAIRSTRIP TECHNOLOGIES, LPK09026902/13/2009
SYMCARE DIABETES MANAGEMENT PROGRAMSYMCARE PERSONALIZED HEALTH SOLUTIONS, INCK08326303/13/2009
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECGMEDICALGORITHMICS SP Z.O.O.K09003705/22/2009
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025INFOPIA CO., LTDK09116805/27/2010
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL, LTD.K10163906/25/2010
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084CARD GUARD SCIENTIFIC SURVIVAL, LTD.K10170307/13/2010
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1WELLDOC, INCK10006607/15/2010
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1AIRSTRIP TECHNOLOGIES, LPK10013307/23/2010
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4AGAMATRIXK10159710/18/2010
AIDERA DIASEND SYSTEMAIDERA ABK10180612/07/2010
MOBIUS ULTRASOUND IMAGING SYSTEMMOBISANTE, INC.K10215301/20/2011
MOBILE MIMMIM SOFTWARE INC.K10378502/04/2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931ANDON HEALTH CO.,LTDK10293902/23/2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM)AIRSTRIP TECHNOLOGIES, LPK11050303/10/2011
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL LTD.K11049904/06/2011
DASH KNEEBRAINLAB AGK10225105/17/2011
WITHINGS BLOOD PRESSURE MONITORWITHINGSK11087205/20/2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAIRSTRIP TECHNOLOGIES, LPK11223508/26/2011
RESOLUTIONMD MOBILE MODEL RMB-MOB-2XCALGARY SCIENTIFIC, INC.K11134609/09/2011
REKA E100REKA PTE LTDK11143809/12/2011
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMWELLDOC, INCK11237010/14/2011
CARESTREAM PACSCARESTREAM HEALTH, INC.K11091910/20/2011
IGLUCOSE SYSTEMPOSITIVEID CORPORATIONK11193211/10/2011
MOBILE MIMMIM SOFTWARE INC.K11293012/02/2011
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV DAGAMATRIX INCK10354412/07/2011
SMARTHEARTSHL TELEMEDICINE INTERNATIONAL LTD.K11351402/22/2012
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMWELLDOC, INCK12031402/24/2012
ORTHOSIZEORTHOSIZE LLCK12011503/14/2012
PIXEL APPGAUSS SURGICAL, INC.K12047304/09/2012
SURGICASE CONNECTMATERIALISE N.V.K11359904/27/2012
PROTEUS INGESTION CONFINMATION SYSTEMSPROTEUS BIOMEDICAL, INC.K11307005/01/2012
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITORANDON HEALTH CO.,LTDK12067206/01/2012
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITORANDON HEALTH CO., LTDK12147006/14/2012
BEAM BRUSH/BEAM APPBEAM TECHNOLOGIES, LLCK12116506/21/2012
PIXEL APPGAUSS SURGICAL, INC.K12127406/27/2012
ASTHMAPOLIS SYSTEMRECIPROCAL LABS CORPORATIONK12160907/02/2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAIRSTRIP TECHNOLOGIES, LPK12187107/03/2012
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECTPREVENTICE, INC.K12119708/10/2012
BIOHARNESSZEPHYR TECHNOLOGY CORPORATIONK11304508/14/2012
AYCAN MOBILEAYCAN DIGITALSYSTEME GMBHK12226009/12/2012
VESTIBULAR ANALYSIS APPARATUSCAPACITY SPORTS, LLCK12159009/20/2012
WITHINGS, SMART BODY SCALEZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.K12197109/27/2012
ALIVECOR HEART MONITOR FOR IPHONEALIVECOR, INC.K12235611/19/2012
PANOPTICWELCH ALLYN, INC.K12140512/20/2012
MYVISIONTRACK(TM)VITAL ART AND SCIENCE INCORPORATEDK12173802/22/2013
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31CALGARY SCIENTIFIC, INC.K12318603/14/2013
INTUITIONTERARECON, INC.K12191604/02/2013
MOBILECT VIEWERNEPHOSITY, INC.K12308205/16/2013
RHYTHMSTAT XLDATA CRITICAL CORP.K97165012/04/1997
MOBILE-PATIENT VIEWERDATA CRITICAL CORPORATIONK01143607/05/2001
MODIFICATION TO: POCKETVIEW ECG SOFTWAREMICROMEDICAL INDUSTRIES, LTD.K01331101/03/2002
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEMABBOTT DIABETES CARE INC.K02086606/11/2002