Data / Medical devices / United States / Swims America Corp
Swims America Corp: FDA-registered device maker in Stamford, CT, United States, 5 510(k) clearances
Swims America Corp is registered with the FDA (registration 3017263740) in Stamford, CT, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017263740
- Address
- 4 Landmark Sq Ste 500, Stamford, CT, United States, 06901
- Owner or operator
- SWIMS AMERICA CORP (10086766)
- Roles
- Complaint file establishment
- First device listed
- December 9, 2022
- Registered through
- 2026
- Brand names listed
- BACK 3SE, BACK 3TX, BACK 4, BACK3 COLOR, RSHOCK, WINBACK, Winback, winback
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| September 14, 2023 | K230167 | BACK 4 | IPF | Substantially Equivalent | Swims America Corp | accessdata.fda.gov |
| July 19, 2023 | K230037 | BACK 3 | PBX | Substantially Equivalent | Swims America Corp | accessdata.fda.gov |
| March 1, 2023 | K220014 | RSHOCK | PBX | Substantially Equivalent | Swims America Corp | accessdata.fda.gov |
| November 1, 2022 | K214090 | Back 3 COLOR | PBX | Substantially Equivalent | Swims America Corp | accessdata.fda.gov |
| September 18, 2017 | K162828 | Winback Back 3SE | PBX | Substantially Equivalent | Winback USA Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Stimulator, Muscle, Powered
Updated September 14, 2023. 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.