Neurolutions, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Neurolutions, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QOL | Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200046 | De Novo | Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser | 2021-04-23 |
Recalls
openFDA lists no recalls under a recalling firm named Neurolutions, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Neurolutions, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05965713: National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke (Completed, started 2023-10-01)
- NCT04338971: Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes (Completed, started 2017-05-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neurolutions, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Neurolutions, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Neurolutions, Inc.?
The most frequent FDA product codes under this applicant name are QOL (Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser, 1).
Next steps
- See all 0 Neurolutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QOL, Neurolutions, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.