510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K152851Substantially Equivalent

BrainPort V100

Wicab, Inc., Middleton WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152851 is the FDA 510(k) clearance record for BrainPort V100, 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 K152851.

Clearance record

Decision date
Received
(86 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. 8313 Greenway Blvd., Suite 100, Middleton WI
510(k) summary
Summary PDF
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