FDA UDI
In Commercial Distribution
🇺🇸 United States
Sway
DI: 00868168000306
·
Model: Sway Sports Plus
·
HEALTHY ROSTER LLC
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Sway
- Primary DI
- 00868168000306
- Version / Model
- Sway Sports Plus
- Company Name
- HEALTHY ROSTER LLC
- Labeler DUNS
- 079916384
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-13
- Public Version
- 1
- Public Version Date
- 2026-04-21
- Public Version Status
- New
- Public Device Record Key
- 8f9d75cc-9a26-4b05-a135-2b8b4c2270c4
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| POM | Computerized Cognitive Assessment Aid For Concussion | Neurology | 882.1471 | 2 |
| LXV | Apparatus, Vestibular Analysis | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63185 | Cognitive assessment software | A software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients. | No | Active |
| 64862 | Balance/cognitive function analysis system | An assembly of devices intended to provide interactive tests for a patient in a clinical setting to assess balance and cognitive status (e.g., attention, concentration, short term memory/recall, motor control). It consists of an electronic floor plate sensor to measure balance deficits, hand controllers (e.g., videogame-like joystick, keyboard) for interactive on-screen tests, and a tablet/software to provide cognitive/motion control tests and comparative assessment results. This device is typically used to screen for and/or monitor patients at risk of fall, who suffered a concussion, or who are affected by dementia or neuromuscular disorders (e.g., Alzheimer’s disease, Parkinson’s disease). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868168000306 | GS1 |