FDA UDI
In Commercial Distribution
🇺🇸 United States
OculoMotor Technologies
DI: 00860012940608
·
Model: VERVE
·
Oculomotor Technologies Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OculoMotor Technologies
- Primary DI
- 00860012940608
- Version / Model
- VERVE
- Company Name
- Oculomotor Technologies Inc.
- Labeler DUNS
- 081121764
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-28
- Public Version
- 2
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- 2a92118f-2bda-4936-b651-a84e9b6ce1fa
Device Description
Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy
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
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| SBN | Digital Therapy Device For Convergence Insufficiency | Ophthalmic | 886.1290 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66912 | Daily routine exercise software | A software program intended to be used on a non-medical computerized device and a display unit (e.g., television) to provide virtual exercise-based interactive activities/games for daily/regular use to help maintain or improve physical/mental health; it is not dedicated to physical rehabilitation. It may be intended for use with one or more type(s) of electronic exercise device(s) [e.g., cycle device] and may provide one or more type(s) of on-screen interaction (e.g., video of a journey). It is not intended to provide specific biomechanical function analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012940608 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232930 | 000 |