Search Results
Found 2 results
510(k) Data Aggregation
K Number
K243603Device Name
AeviceMD
Manufacturer
Aevice Health Pte. Ltd.
Date Cleared
2025-05-05
(165 days)
Product Code
DSH
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
Aevice Health Pte. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from pediatric patients (aged 3 years and above) in a clinical or non-clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
Device Description
The AeviceMD is designed as an electronic stethoscope to acquire and record lung sounds from users for healthcare professionals (HCP) to playback and interpret the sounds recorded. AeviceMD does not contain any alarm feature and it is not intended for emergency use. It is also not a sleep apnea device. The device is not intended for self-diagnosis.
The AeviceMD consists of hardware and embedded software. It is a five-part system that includes the following components:
1. **AeviceMD Sensor** – an embedded electronic wearable device that detects and records lung sounds and transmits data to an electronic gateway via Bluetooth.
2. **AeviceMD Silicone Patch** – silicone patch that houses and attaches the Sensor to the user's body (i.e., chest). This silicone patch undergoes biocompatibility testings which allow AeviceMD Sensor to be worn on the skin.
3. **AeviceMD Docking Station** – gateway device that serves as a computational hub and linkage from the Sensor to the Cloud Platform, and as a charger for the Sensor.
4. **AeviceMD App (for patients) / AeviceMD HCP Web App (for healthcare professionals)** - The AeviceMD App is a mobile app that downloads the post-processed information from the Cloud Platform and presents users with their recorded lung sounds at the auscultation locations which they can share with their HCP during their next consultation. A separate app, AeviceMD HCP Web App is tailored for HCP to review their patient's data in a clinical setting.
5. **AeviceMD Cloud Platform** – secure cloud server that receives data from gateway units and analyzes user's data using meaningful output information.
Ask a Question
K Number
K223382Device Name
AeviceMD
Manufacturer
Aevice Health Pte. Ltd.
Date Cleared
2023-07-07
(242 days)
Product Code
DSH, DOD
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
Aevice Health Pte. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from adult patients in a clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
Device Description
The AeviceMD is designed as an electronic stethoscope to acquire and record lung sounds from users for healthcare professionals (HCP) to playback and interpret the sounds recorded. AeviceMD does not contain any alarm feature and it is not intended for emergency use. It is also not a sleep apnea device. The device is not intended for self-diagnosis.
The AeviceMD consists of hardware and embedded software. It is a five-part system that includes the following components:
1. AeviceMD Sensor – an embedded electronic wearable device that detects and records lung sounds and transmits data to an electronic gateway via Bluetooth.
2. AeviceMD Silicone Patch - silicone patch that houses and attaches the Sensor to the user's body (i.e., chest). This silicone patch undergoes biocompatibility testings which allow AeviceMD Sensor to be worn on the skin.
3. AeviceMD Docking Station - gateway device that serves as a computational hub and linkage from the Sensor to the Cloud Platform, and as a charqer for the Sensor.
4. AeviceMD App (for patients) / AeviceMD HCP Web App (for healthcare professionals in a clinical setting) - The AeviceMD App is a mobile app that downloads the post-processed information from the Cloud Platform and presents users with their recorded lung sounds at the auscultation locations which they can share with their HCP during their next consultation. A separate app, AeviceMD HCP Web App is tailored for HCP to review their patient's data in a clinical setting.
5. AeviceMD Cloud Platform – secure cloud server that receives data from gateway units and analyzes user's data using meaningful output information.
Ask a Question
Page 1 of 1