DEVICE DETAILS
| NAME OF DEVICE | PULSE WAVE A-FIB PROMPT APP |
|---|---|
| ESTABLISHMENT NAME | HUAWEI TECHNOLOGIES (MALAYSIA) SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB7138225-216992 |
| BRAND NAME | HUAWEI |
| MEDICAL DEVICE CATEGORY | MD 0100 - GENERAL NON-ACTIVE, NON-IMPLANTABLE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | SINGLE |
| DEVICE DESCRIPTION | The Pulse Wave A-fib Prompt App is an independent app that works with Huawei wearable devices. It analyzes pulse data to identify irregular heart rhythms and notifies users of suspected atrial fibrillation (A-fib). Users can actively collect data or enable automatic data collection in the background. When users choose to enable automatic data collection in the background, the app does not send a notification every time it detects suspected A-fib, so no notification does not mean that there is no irregularity. This data is only collected when the user is still. The app can be used to supplement the decision for A-fib screening. The app is not intended to diagnosis of atrial fibrillation. The app should not be used by anyone under the age of 18. |
| DEVICE INTENDED PURPOSE | The Pulse Wave A-fib Prompt App is an independent app that works with Huawei wearable devices. It analyzes pulse data to identify irregular heart rhythms and notifies users of suspected atrial fibrillation (A-fib). Users can actively collect data or enable automatic data collection in the background. When users choose to enable automatic data collection in the background, the app does not send a notification every time it detects suspected A-fib, so no notification does not mean that there is no irregularity. This data is only collected when the user is still. The app can be used to supplement the decision for A-fib screening. The app is not intended to diagnosis of atrial fibrillation. The app should not be used by anyone under the age of 18. |
| VALIDITY DATE OF REGISTRATION | 19/11/2025 - 18/11/2030 |