The Smartpill Corporation
United StatesFDA applicant, unverified
- Devices
- 2
What The Smartpill Corporation makes
The Smartpill Corporation manufactures ingestible capsule-based systems for gastrointestinal (GI) monitoring, including the Smartpill GI Monitoring System and its updated version 2.0. These devices record internal pH, pressure, and temperature data to assess GI transit time and motility, aiding in diagnostic evaluations for conditions like acid reflux or bowel obstruction.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Smartpill Gi Monitoring System Ref K053547
Regimes: 510(k) Registry: 510(k)Smartpill Gi Monitoring System, Version 2.0 Ref K092342
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does The Smartpill Corporation have in the registry?
The registry currently lists 2 devices for The Smartpill Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Smartpill Corporation's devices?
Among its 2 most recently registered devices, The Smartpill Corporation has devices listed in FDA 510(k) (2 devices).
What risk classes do The Smartpill Corporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for The Smartpill Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from The Smartpill Corporation in the registry?
The most recently registered devices listed for The Smartpill Corporation include SMARTPILL GI MONITORING SYSTEM and SMARTPILL GI MONITORING SYSTEM, VERSION 2.0.