Data / Medical devices / United States / Sway Medical, Inc.
Sway Medical, Inc.: FDA-registered device maker in Tulsa, OK, United States, 2 510(k) clearances
Sway Medical, Inc. is registered with the FDA (registration 3010325634) in Tulsa, OK, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010325634
- Address
- 32 S. Lewis Ave, Tulsa, OK, United States, 74104
- Owner or operator
- Sway Medical, Inc (10044583)
- Roles
- Manufacturer
- First device listed
- June 28, 2013
- Registered through
- 2026
- Brand names listed
- Sway Balance, Sway Cognitive, Sway Sports+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Vestibular Analysis | LXV | U | Manufacturer | accessdata.fda.gov |
| Computerized Cognitive Assessment Aid For Concussion | POM | 2 | Manufacturer | accessdata.fda.gov |
| Computerized Cognitive Assessment Aid, Exempt | PTY | 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 |
|---|---|---|---|---|---|---|
| February 15, 2025 | K241737 | Sway System Sports Plus | POM | Substantially Equivalent | Sway Medical, Inc. | accessdata.fda.gov |
| September 20, 2012 | K121590 | VESTIBULAR ANALYSIS APPARATUS | LXV | Substantially Equivalent | Capacity Sports, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Vestibular Analysis
- All makers of Computerized Cognitive Assessment Aid For Concussion
- All makers of Computerized Cognitive Assessment Aid, Exempt
Updated February 15, 2025. 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.