Data / Medical devices / United States / MiniStim Corp
MiniStim Corp: FDA-registered device maker in Boca Raton, FL, United States, 1 510(k) clearance
MiniStim Corp is registered with the FDA (registration 3016547665) in Boca Raton, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 14, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016547665
- Address
- 1900 Glades Road Suite 500, Boca Raton, FL, United States, 33431
- Owner or operator
- MiniStim Corp (10062396)
- Roles
- Manufacturer
- First device listed
- August 17, 2020
- Registered through
- 2026
- Brand names listed
- Ministim PNS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | 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 |
|---|---|---|---|---|---|---|
| August 14, 2020 | K200848 | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit | GZF | Substantially Equivalent | Micron Medical Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Spinal-Cord, Implanted (Pain Relief)
- All makers of Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Updated August 14, 2020. 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.