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PROTEUS DIGITAL HEALTH, INC.

United States(FDA 510(k) applicant) Last updated 23 May 2026

Devices
31
Registries
GUDIDFDA 510(k)
FDA recalls
0

Catalogue31

What PROTEUS DIGITAL HEALTH, INC. makes

The company manufactures post-ingestion medication adherence telemetric monitoring systems, including wearable patches with ingestible sensors that track when patients take prescribed medications. These systems provide real-time feedback on adherence via connected devices, supporting remote monitoring and patient compliance tracking.

The portfolio consists of Class II medical devices authorised through FDA 510(k) clearance and listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Proteus Digital Health, Inc. manufacture?

Proteus Digital Health, Inc. specializes in post-ingestion medication adherence telemetric monitoring systems. These devices include wearable patches equipped with ingestible sensors that detect when a patient swallows their medication. The systems then transmit real-time data to connected devices, enabling remote monitoring and tracking of patient adherence to prescribed treatment plans.

Where is Proteus Digital Health, Inc. based?

Proteus Digital Health, Inc. is headquartered in the United States. The company’s location is relevant for regulatory oversight and compliance, as its devices are authorised under U.S. medical device regulations.

Which regulatory registries or databases list Proteus Digital Health, Inc.’s devices?

Proteus Digital Health, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database and have undergone FDA 510(k) clearance. These registries ensure traceability and compliance tracking for Class II medical devices authorised in the U.S.

How are Proteus Digital Health, Inc.’s devices classified under medical device regulations?

Proteus Digital Health, Inc.’s devices fall under Class II classification in the U.S. This classification is assigned based on the risk associated with the device’s intended use—here, monitoring medication adherence via telemetric systems. Class II devices typically require premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States(Country (from FDA 510(k) applicant address))
DUNS number
149825791