Nimbleheart, Inc.
United Statesfrom the FDA registration address FDA FEI 3021219789
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Nimbleheart, Inc. makes
Nimbleheart, Inc. manufactures the Physiotrace system, a medical device designed for monitoring and analyzing physiological signals to support cardiac and respiratory assessments in clinical settings.
The Physiotrace system is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
Physiotrace Ref K171244
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3021219789
- DUNS number
- 079081748
- Address
- 1180 Miraloma Way, Sunnyvale, CA, 94085
Frequently asked questions
How many devices does Nimbleheart, Inc. have in the registry?
The registry currently lists 3 devices for Nimbleheart, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nimbleheart, Inc.'s devices?
Among its 3 most recently registered devices, Nimbleheart, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nimbleheart, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Nimbleheart, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nimbleheart, Inc. in the registry?
The most recently registered devices listed for Nimbleheart, Inc. include Physiotrace Smart and Physiotrace.