SEARCH RESULTS FOR: APP企业签扑克企业签名-(TG:qiankunkeji8).kgd(2370 results)

reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.

reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.

reSET® Mobile Application running on Android. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.

reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.

The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.

ENHANCED ALGORITHM ECG EVENT RECORDER https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652#

B-P KNEE TIBIA PLATFORM COMPONENT, W/O BIOCOAT, W/ULTRACOAT, TYPE 0, SIZE 2 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.). This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420

LAP-Instrument, Ø10mm, l=450mm, detach. Grasping forceps TENACULUM, d/a Stainl.steel handle, insul., w/o ratchethttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.

The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.

No Description

Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)

The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.

The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.

OtoNova Pro system for ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and ABR Screener licence for the Nova-link app

OtoNova Pro system for DPOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP Screener licence for the Nova-link app

OtoNova Pro system for TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE Screener licence for the Nova-link app

Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.

OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app

OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app

OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app

Kinesia Web Application/Portal 2 Software

Parky App is a symptom tracker mobile app for Parkinson’s Disease patients. It collects motion data through Apple Watch continuously and quantifies tremor and dyskinesia episodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcare professional through email.

OtoNova Pro system for Clinical OAE and ABR hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app

OtoNova Pro system for DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+ABR Screener licence for the Nova-link app

OtoNova Pro system for TEOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE+ABR Screener licence for the Nova-link app

OtoNova Pro system for DPOAE and TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+TE Screener licence for the Nova-link app