Product code PIC
- Device name
- Oral Electronic Vision Aid
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.5905
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K152851 | BrainPort V100 | Wicab, Inc. | 2015-12-24 |
| DEN130039 | BRAINPORT V100 DEVICE | Wicab, Inc. | 2015-06-18 |