Data / Medical devices / United States / Fist Assist Devices, LLC
Fist Assist Devices, LLC: FDA-registered device maker in Las Vegas, NV, United States, 1 510(k) clearance
Fist Assist Devices, LLC is registered with the FDA (registration 3016910466) in Las Vegas, NV, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 17, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016910466
- Address
- 3060 E. Post Road, Suite 110, Las Vegas, NV, United States, 89120
- Owner or operator
- Fist Assist Devices, LLC (10082322)
- Roles
- Specification developer
- First device listed
- July 9, 2021
- Registered through
- 2026
- Brand names listed
- Fist Assist
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 17, 2021 | K210281 | Fist Assist Devices Model FA-1 | IRP | Substantially Equivalent | Fist Assist Devices, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 17, 2021. 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.