510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834462Substantially Equivalent

Genucom

Far Orthopedics, Inc., MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834462 is the FDA 510(k) clearance record for GENUCOM, a class I device, cleared for Far Orthopedics, Inc. on under FDA product code LYH (Arthrometer). FDA records list 2 510(k) clearances for Far Orthopedics, Inc., from to . As of , FDA records show no recalls naming K834462.

Clearance record

Decision date
Received
(52 days to decision)
Product code
LYH Arthrometer
Regulation
21 CFR 890.1615
Device class
Class I
Review panel
Physical Medicine
Applicant
Far Orthopedics, Inc.
Third party review
No

Clearances, product code LYH

Trailing 12 months

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

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