Table 1 Examples of FDA endorsed mobile apps. (For a complete list, please refer to Supplementary Table S1).
Device Name | Applicant | 510(k) Number | Type | Measure | Disease |
|---|---|---|---|---|---|
Airstrip Ob | Airstrip Technologies, Lp | K090269 | Monitoring | Fetal Heart Tracings; Maternal Contraction Pattern | Obstetrics/Gynecology |
Alivecor Heart Monitor For Iphone | Alivecor, Inc. | K122356 | Monitoring | Ecg | Cardiovascular |
Beam Brush/Beam App | Beam Technologies, Llc | K121165 | Monitoring | Brushing Usage Data | Tooth Decay |
Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect | Preventice, Inc. | K121197 | Monitoring | Ecg; Activity; Heart Rate; Respiration Rate | Cardiovascular |
Cg-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | K060911 | Monitoring | Ecg | Cardiac Arrhythmia |
Customized Sound Therapy (Cst) | Tinnitus Otosound Products, Llc | K070599 | Treatment | Â | Tinnitus |
Freestyle Tracker Diabetes Management System | Abbott Diabetes Care Inc. | K020866 | Monitoring | Glucose | Diabetes |
Fully Automatic Wireless Blood Pressure Wrist Monitor | Andon Health Co., Ltd | K121470 | Monitoring | Blood Pressure | Cardiovascular |
Iglucose System | Positiveid Corporation | K111932 | Monitoring | Glucose | Diabetes |
Intuition | Terarecon, Inc. | K121916 | Data Viewer | Ebt, Ct, Pet Or Mri Image | Â |
Kd-936 Fully Automatic Wireless Blood Pressure Monitor | Andon Health Co.,Ltd | K120672 | Monitoring | Blood Pressure | Cardivascular |
Medicalgorithmics Real-Time Ecg Monitor And Arrhythmia Detector, Model Pocketecg | Medicalgorithmics Sp Z.O.O. | K090037 | Monitoring | Heart Beat, Rhythm Abnormalities | Cardivascular |
Mobile Mim | Mim Software Inc. | K112930 | Data Viewer | Spect, Pet, Ct, Mri, X-Ray And Ultrasound | Â |
Myglucohealth Glucose Monitoring Systems | Entra Health Systems, Ltd. | K081703 | Monitoring | Glucose | Diabetes |
Myvisiontrack(Tm) | Vital Art And Science Incorporated | K121738 | Monitoring | Central 3 Degrees Metamorphopsia (Visual Distortion) | Maculopathy |
Proteus Ingestion Confinmation Systems | Proteus Biomedical, Inc. | K113070 | Monitoring | Physiological And Behavioral Metrics Including Heart Rate, Activity, Body Angle And Time-Stamped User-Logged Events | General |
Rhythmstat Xl | Data Critical Corp. | K971650 | Diagnostic | Ecg | Cardiovascular |
Sd360 Digital Recorder/Sd360 Holter Digital Recorder | Northeast Monitoring, Inc. | K041901 | Monitoring | Heart Beat | Cardiovascular |
Silhouette, Model 1000.01 | Aranz Medical Limited | K070426 | Monitoring | External Wounds | External Wounds |
Smartheart | Shl Telemedicine International Ltd. | K113514 | Monitoring | Lead Egg And Rhythm Strip | Cardiovascular |
Veo Multigas Monitor For Pocket Pc, Model 400221 | Weissburg Associates | K051857 | Monitoring | Carbon Dioxide; Oxygen | Anesthesiology |
Vestibular Analysis Apparatus | Capacity Sports, Llc | K121590 | Monitoring | Balance | Â |
Welldoc Diabetes Manager System And Diabetes Manager Rx System | Welldoc, Inc | K120314 | Monitoring | Glucose | Diabetes |
Withings Blood Pressure Monitor | Withings | K110872 | Monitoring | Blood Pressure | Cardiovascular |
