Modus Health, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000026340 FEI 3010817595
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Advena LimitedMT
What Modus Health, LLC makes
Modus Health, LLC manufactures the StepWatch, a wearable device designed to monitor and record physical activity, specifically step count and movement patterns, for clinical and research applications. The device is intended for use in assessing mobility, rehabilitation progress, and activity levels in patients.
The StepWatch is classified as a Class I medical device under regulatory frameworks and is registered in the EU’s eudamed database. The company is based in the United States.
Catalogue
Company details
- EUDAMED SRN
- US-MF-000026340
- FDA FEI number
- 3010817595
- DUNS number
- 078855932
- EUDAMED status
- Active
- EUDAMED registered name
- Modus Health, LLC
- Registered address
- 6100, 219th St SW, 98043, Mountlake Terrace, United States
- Website
- www.modushealth.com
- [email protected]
- PRRC contact
- Alberto Corona-Lopez
Frequently asked questions
How many devices does Modus Health, LLC have in the registry?
The registry currently lists 2 devices for Modus Health, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Modus Health, LLC's devices?
Among its 2 most recently registered devices, Modus Health, LLC has devices listed in EUDAMED (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Modus Health, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Modus Health, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Modus Health, LLC in the registry?
The most recently registered devices listed for Modus Health, LLC include StepWatch.