Wearable health monitor
A wearable health monitor is a device worn on the body that records signals such as heart rate, ECG, oxygen saturation, activity or temperature and sends the data to an app or platform. It is used for remote patient monitoring, home care and telemedicine programmes.
Common types
- Wearable ECG patch: records ECG continuously for several days.
- Health watch: wrist device measuring heart rate, SpO2 and activity.
- Remote monitoring kit: several connected devices with a hub for home patients.
- Wearable temperature patch: continuous temperature monitoring.
- Fall detection device: alerts carers when an elderly person falls.
What to tell us when you ask for a quotation
- Parameters measured and whether each is a regulated medical function.
- Wear time, battery life and charging method.
- Data connection: Bluetooth, cellular, app and platform.
- Data hosting location and privacy requirements.
- Integration with hospital systems.
- Quantity, destination country and the delivery terms you want (for example EXW, FOB or CIF).
Documents to ask for
Buyers ask whether each measuring function has CE marking under the EU MDR or US FDA clearance, as many consumer wearables are not medical devices. ISO 13485 for the maker, IEC 60601-1-11 for home use and data protection documents are also requested.
Certificates and registrations belong to the product and its manufacturer. We check them with you against the rules of your market before any order.
Is a smartwatch with health functions a medical device?
Only the functions for which the maker holds FDA clearance or CE marking as medical functions are medical devices. Check the labelling and certificates for each function you plan to use clinically.
Send us the specification and quantity. We compare manufacturers in China and reply with options, lead times and the documents that come with each product. NJMC sources and checks; it does not manufacture.