Carelink
Country not established
- Devices
- 2
What Carelink makes
Carelink manufactures telehealth communication devices, including the HealthPhone Toco Model and HealthPhone, designed for remote patient monitoring and medical call management. These devices facilitate voice and data transmission for clinical use, supporting real-time communication between patients and healthcare providers.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the U.S., where Carelink is based.
Catalogue
Healthphone Toco Model Ref K874631
Regimes: 510(k) Registry: 510(k)Healthphone(Tm) Ref K862668
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Carelink have in the registry?
The registry currently lists 2 devices for Carelink. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carelink's devices?
Among its 2 most recently registered devices, Carelink has devices listed in FDA 510(k) (2 devices).
What risk classes do Carelink's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Carelink's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Carelink in the registry?
The most recently registered devices listed for Carelink include HEALTHPHONE TOCO MODEL and HEALTHPHONE(TM).