510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130039Unknown

Brainport V100 Device

Wicab, Inc., Philedelphia PA / Direct, Unknown
FDA source (opens on fda.gov)

DEN130039 is the FDA 510(k) clearance record for BRAINPORT V100 DEVICE, a class II device, cleared for Wicab, Inc. on under FDA product code PIC (Oral Electronic Vision Aid). FDA's definition for product code PIC reads: "To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)". FDA records list one 510(k) clearance for Wicab, Inc. As of , FDA records show no recalls naming DEN130039.

Clearance record

Decision date
Received
(680 days to decision)
Product code
PIC Oral Electronic Vision Aid
Regulation
21 CFR 886.5905
Device class
Class II
Review panel
Ophthalmic
Applicant
Wicab, Inc. 1835 Market St., 29th Floor, Philedelphia PA
Third party review
No

Clearances, product code PIC

Trailing 12 months

FDA records hold no clearances under product code PIC in the trailing twelve months.

FDA records show no clearances under product code PIC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PIC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260