Data / Medical devices / United States / Swimex Systems
Swimex Systems: FDA-registered device maker in Fall River, MA, United States, 1 510(k) clearance
Swimex Systems is registered with the FDA (registration 1223754) in Fall River, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 9, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1223754
- FEI number
- 1000220171
- Address
- 390 Airport Rd, Fall River, MA, United States, 02720
- Owner or operator
- SwimEx, INC (9010519)
- Roles
- Manufacturer
- First device listed
- February 2, 2011
- Registered through
- 2026
- Brand names listed
- SwimEx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Powered | BXB | 1 | 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 |
|---|---|---|---|---|---|---|
| January 9, 1995 | K935011 | SWIMEX MULTIDEPTH POOL (MODEL 600T) | BXB | Substantially Equivalent | Swimex Systems | accessdata.fda.gov |
Compare with other makers
Updated January 9, 1995. 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.