Noctrix Health, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Noctrix Health, 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 |
|---|---|---|---|
| QWD | Stimulator, Nerve, For Restless Legs Syndrome | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220059 | De Novo | Stimulator, Nerve, For Restless Legs Syndrome | 2023-04-17 |
Recalls
openFDA lists no recalls under a recalling firm named Noctrix Health, 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 Noctrix Health, Inc. is the lead sponsor of 7 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06866132: Response to an Investigational Device in Patients With Restless Legs Syndrome (Active not recruiting, started 2025-03-11)
- NCT06076499: A Post-Market Study for Long-Term Effectiveness and Safety of the TOMAC System for RLS (Active not recruiting, started 2023-11-15)
- NCT05214963: Noninvasive Peripheral Nerve Stimulation for Medication-Naive and Medication-Refractory RLS (Completed, started 2022-03-08)
- NCT05196828: Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS (Completed, started 2021-12-20)
- NCT04874155: Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study) (Completed, started 2021-05-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Noctrix Health, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Noctrix Health, 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 Noctrix Health, Inc.?
The most frequent FDA product codes under this applicant name are QWD (Stimulator, Nerve, For Restless Legs Syndrome, 1).
Next steps
- See all 0 Noctrix Health, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QWD, Noctrix Health, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.