Fusmobile, Inc.: FDA clearances and approvals
Fusmobile, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel. It is the industry lead sponsor of 5 device clinical trials on ClinicalTrials.gov.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SGN | High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250015 | De Novo | High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation | 2025-11-14 |
Recalls
openFDA lists no recalls under a recalling firm named Fusmobile, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Fusmobile, Inc. is the industry lead sponsor of 5 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07178951: Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis (Recruiting, started 2026-01)
- NCT06053255: Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis (Recruiting, started 2024-09-13)
- NCT05154448: Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain (Completed, started 2022-05-16)
- NCT04519541: RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain (Completed, started 2021-02-03)
- NCT03321344: Safety and Initial Feasibility of Using the Neurolyser for Facet Related Low Back Pain (Completed, started 2017-12-05)
Frequently asked questions
How many FDA 510(k) clearances does Fusmobile, Inc. have?
Fusmobile, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Fusmobile, Inc. make?
Its most frequent FDA product codes are SGN (High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation, 1).
Has Fusmobile, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Fusmobile, Inc. Related entities may recall under other names.
Next steps
- See all 0 Fusmobile, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SGN, Fusmobile, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.