510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897179Substantially Equivalent

Orbiter(tm) Treadmill

Lee-Meredith Industries, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897179 is the FDA 510(k) clearance record for ORBITER(TM) TREADMILL, a class I device, cleared for Lee-Meredith Industries, Inc. on under FDA product code IOL (Treadmill, Powered). FDA records list one 510(k) clearance for Lee-Meredith Industries, Inc. As of , FDA records show no recalls naming K897179.

Clearance record

Decision date
Received
(49 days to decision)
Product code
IOL Treadmill, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Lee-Meredith Industries, Inc. 6304 Alder, Houston TX
Third party review
No

Clearances, product code IOL

Trailing 12 months

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

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