Data / Medical devices / United States / SetPoint Medical Corporation
SetPoint Medical Corporation: FDA-registered device maker in Valencia, CA, United States, 1 PMA approval
SetPoint Medical Corporation is registered with the FDA (registration 3013688988) in Valencia, CA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated July 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013688988
- Address
- 25101 Rye Canyon Loop, Valencia, CA, United States, 91355
- Owner or operator
- SetPoint Medical (10093217)
- Roles
- Manufacturer
- First device listed
- July 31, 2025
- Registered through
- 2026
- Brand names listed
- SetPoint Charger, SetPoint Charger and Docking Station, SetPoint Docking Station, SetPoint Implant, SetPoint Programmer, SetPoint System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vagus Nerve Stimulator For Rheumatoid Arthritis | SFJ | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 30, 2025 | P240039 | SetPoint System | SFJ | 3 | October 16, 2026 | accessdata.fda.gov |
Compare with other makers
Updated October 16, 2026. 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.