510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801250Substantially Equivalent

Hydra Tred Dc

Medichanics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801250 is the FDA 510(k) clearance record for HYDRA TRED DC, a class I device, cleared for Medichanics, Inc. on under FDA product code IOG (Treadmill, Mechanical). FDA records list one 510(k) clearance for Medichanics, Inc. As of , FDA records show no recalls naming K801250.

Clearance record

Decision date
Received
(20 days to decision)
Product code
IOG Treadmill, Mechanical
Regulation
21 CFR 890.5370
Device class
Class I
Review panel
Physical Medicine
Applicant
Medichanics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IOG

Trailing 12 months

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

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