FDA UDI
In Commercial Distribution
🇺🇸 United States
K-D Balance
DI: 00199874750514
·
Model: 2.0
·
King-Devick Test, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- K-D Balance
- Primary DI
- 00199874750514
- Version / Model
- 2.0
- Catalog Number
- 2.0
- Company Name
- King-Devick Test, Inc.
- Labeler DUNS
- 964658723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-03
- Public Version
- 1
- Public Version Date
- 2026-03-11
- Public Version Status
- New
- Public Device Record Key
- 9f22ffa9-0ccc-47b1-b97f-4f1435aad391
Device Description
Software used in smart phone to determine balance
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LXV | Apparatus, Vestibular Analysis | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62949 | Sports concussion screening software | A software program intended to be used on a non-medical computerized device (e.g., smartphone, tablet) to measure, record, and display a range of psychophysical parameters (e.g., eye movement, attention, speech, concentration) for the evaluation of sports-acquired concussions. It provides a visual stimulus test (e.g., text for audible reading) and is intended to be used sideline by laypersons (e.g., sports coach) or medical professionals and during contact or collision sports events to rapidly screen a patient for head trauma injuries; it does not require clinical consultation prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00199874750514 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173669 | 000 |