510(k) DEN130039
DEN130039 is an FDA 510(k) premarket notification submitted by Wicab, Inc. for the device "BRAINPORT V100 DEVICE". The FDA issued a decision of De Novo Granted on June 18, 2015. The device falls under product code PIC (Oral Electronic Vision Aid), a Class II device regulated under 21 CFR 886.5905. Wicab, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 18, 2015
- Date Received
- August 7, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oral Electronic Vision Aid
- Device Class
- Class II
- Regulation Number
- 886.5905
- Review Panel
- OP
- Submission Type
To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)