Aframe Digital, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Aframe Digital, Inc. makes
Aframe Digital, Inc. manufactures the MobileCare Monitor, including the Model 2100 variant, which is designed for remote patient monitoring and telehealth applications. These devices are intended to track vital signs and health metrics for outpatient use.
The company’s products are regulated under FDA’s 510(k) pathway and fall into Class I and Class II device classifications. The MobileCare Monitor and its variants are listed in the FDA’s 510(k) registry, and the company is based in the United States.
Catalogue
Mobilecare Monitor Ref K122333
Regimes: 510(k) Registry: 510(k)Mobilecare Monitor, Model 2100 Ref K090138
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aframe Digital, Inc. have in the registry?
The registry currently lists 2 devices for Aframe Digital, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aframe Digital, Inc.'s devices?
Among its 2 most recently registered devices, Aframe Digital, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Aframe Digital, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Aframe Digital, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aframe Digital, Inc. in the registry?
The most recently registered devices listed for Aframe Digital, Inc. include MOBILECARE MONITOR and MOBILECARE MONITOR, MODEL 2100.