510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K930253Substantially Equivalent

Cardio2 Ctcke

Ergometrx, Inc., Findley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930253 is the FDA 510(k) clearance record for CARDIO2 CTCKE, a class II device, cleared for Ergometrx, Inc. on under FDA product code ISD (Exerciser, Measuring). FDA records list one 510(k) clearance for Ergometrx, Inc. As of , FDA records show no recalls naming K930253.

Clearance record

Decision date
Received
(272 days to decision)
Product code
ISD Exerciser, Measuring
Regulation
21 CFR 890.5360
Device class
Class II
Review panel
Physical Medicine
Applicant
Ergometrx, Inc. 6470 Riverview Ter., Findley MN
510(k) summary
Statement
Third party review
No

Clearances, product code ISD

Trailing 12 months

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

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