510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K911416Substantially Equivalent

Elite System

Gfb Intl. Trading, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911416 is the FDA 510(k) clearance record for ELITE SYSTEM, a class II device, cleared for Gfb Intl. Trading, Inc. on under FDA product code LXJ (Interactive Rehabilitation Exercise Devices). FDA records list one 510(k) clearance for Gfb Intl. Trading, Inc. As of , FDA records show no recalls naming K911416.

Clearance record

Decision date
Received
(66 days to decision)
Product code
LXJ Interactive Rehabilitation Exercise Devices
Regulation
21 CFR 890.5360
Device class
Class II
Review panel
Physical Medicine
Applicant
Gfb Intl. Trading, Inc. 46 Trinity Pl., New York NY
Third party review
No

Clearances, product code LXJ

Trailing 12 months

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

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