FDA Registration
Active
🇺🇸 United States
Sway Medical, Inc.
Reg #: 3010325634
·
FEI: 3010325634
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Sway Medical, Inc.
- Registration Number
- 3010325634
- FEI Number
- 3010325634
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 32 S. Lewis Ave
- City
- Tulsa
- State
- OK
- ZIP
- 74104
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241737
Owner / Operator
- Firm Name
- Sway Medical, Inc
- Operator Number
- 10044583
- Address
- 32 S. Lewis Ave
- City
- Tulsa
- State
- OK
- Postal Code
- 74104
- Country
- US
- Correspondent
- Chase Curtiss
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computerized Cognitive Assessment Aid For Concussion | POM | Class 2 | Neurology | No | 2025-03-03 |
| Apparatus, Vestibular Analysis | LXV | Class U | Unknown | No | 2013-06-28 |
| Computerized Cognitive Assessment Aid, Exempt | PTY | Class 2 | Neurology | No | 2019-03-11 |
Proprietary Names
Sway Sports+
Sway Balance
Sway Cognitive
Establishment Types
Manufacture Medical Device