Data / Medical devices / United States / Neurolutions
Neurolutions: FDA-registered device maker in Van Nuys, CA, United States, 1 510(k) clearance
Neurolutions is registered with the FDA (registration 3030779215) in Van Nuys, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030779215
- Address
- 7033 Hayvenhurst Ave, Van Nuys, CA, United States, 91406
- Owner or operator
- Neurolutions, Inc. (10085797)
- Roles
- Manufacturer
- First device listed
- August 10, 2022
- Registered through
- 2026
- Brand names listed
- Neurolutions IpsiHand Upper Extremity Rehabilitation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser | QOL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 23, 2021 | DEN200046 | Neurolutions Upper Extremity Rehabilitation System | QOL | Unknown | Neurolutions, Inc. | accessdata.fda.gov |
Updated April 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.