510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843702Substantially Equivalent

Apparatus & Methods Self-Exam of Eye

Wheel Checkers, Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843702 is the FDA 510(k) clearance record for APPARATUS & METHODS SELF-EXAM OF EYE, a class I device, cleared for Wheel Checkers on under FDA product code HOQ (Grid, Amsler). FDA records list 2 510(k) clearances for Wheel Checkers, from to . As of , FDA records show no recalls naming K843702.

Clearance record

Decision date
Received
(104 days to decision)
Product code
HOQ Grid, Amsler
Regulation
21 CFR 886.1330
Device class
Class I
Review panel
Ophthalmic
Applicant
Wheel Checkers 2020 S. Bannock St., Denver CO
Third party review
No

Clearances, product code HOQ

Trailing 12 months

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

FDA records show no clearances under product code HOQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HOQ, 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