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reSET-O® Mobile Application running on iOS. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008118 ()
- Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to:
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008088 ()
- Mental health/function therapeutic software, screen-viewed
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution
- 09351356000048 ()
- Phonocardiograph
- Stethoscope application software
Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5503-06-300
In Commercial Distribution
- 00817491024268 ()
FG-5503-06-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution
- 00817491023605 ()
FG-5501-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution
- 00817491022370 ()
FG-5501-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5500-01-300
Not in Commercial Distribution
- 00817491020819 ()
FG-5500-01-300
- Implantable glucose monitoring system
An iOS mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-08
In Commercial Distribution
- 00850049194037 ()
- Air-conduction hearing aid, receiver-in-canal
An iOS platform mobile application used to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-10
In Commercial Distribution
- 00850049194013 ()
- Air-conduction hearing aid, receiver-in-canal
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.
Astellas Pharma Us, Inc.
iOS (Version 1)
In Commercial Distribution
- 00304692416089 ()
DIGI-001
- Medication reminder application software
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution
- 09413000126259 ()
- Electronic goniometer/kinesiology sensor
No Description
Ouraring Inc.
Fertile Window iOS
In Commercial Distribution
- 06430060159990 ()
- Menstrual cycle self-monitoring software
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution
- 05713495000053 ()
84601063
- Medication reminder application software
No Description
EMPATICA SRL
EpiMonitor App iOS
In Commercial Distribution
- 00853858006379 ()
- Home seizure monitoring system
No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution
- 00853858006249 ()
- Multiple vital physiological parameter monitoring system, home-use
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
It is available for prescription only.
SUBLIMED
actiTENS iOS app
In Commercial Distribution
- B786SBM2AA2100 ()
SBM2AA210
- Analgesic transcutaneous electrical nerve stimulation system
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution
- 00884838127432 ()
989803221531
- Centralized patient monitor
FLOWMETER ASSY,MDM-CAN.
PARKER-HANNIFIN CORPORATION
91500167
In Commercial Distribution
- 00816711020219 ()
- Oxygen/air/nitrous oxide breathing gas mixer
Single use disposable application pad adhesive for use with dorsaVi Version 5 MDM Sensors for Movement Suite Kits.
DORSAVI LTD
30Min-DAP
In Commercial Distribution
- B758000035630 ()
- B758000RDA326 ()
0356-30
- Psychophysiological biofeedback system
A native iOS and Android mobile application also compatible with iPad. It is used to:
• Locate patients according to patient ID
• Locate scheduled procedures by connecting to modality worklist
• Capture videos, images and audio files to be included in the study case.
• Add notes and tags to each file (asset).
• Upload any file to the Orpheus System
• Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution
- 07290017025100 ()
MLL-EG30001
- Radiology information system application software