Cleared Traditional

K930253 - CARDIO2 CTCKE

K930253 is an FDA 510(k) clearance for CARDIO2 CTCKE, manufactured by Ergometrx, Inc.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K930253 · Ergometrx, Inc. · Physical Medicine device
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Oct 1993
Decision
272d
Days
Class 2
Risk

K930253 is an FDA 510(k) clearance for the CARDIO2 CTCKE. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Ergometrx, Inc. (Findley, US). The FDA issued a Cleared decision on October 18, 1993 after a review of 272 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Ergometrx, Inc. devices

FDA 510(k) Submission Details - K930253

510(k) Number K930253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date October 18, 1993
Days to Decision 272 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 115d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ISD Exerciser, Measuring

All 27
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K930253.
UPPER BODY EXERCISER
K926279 · Henley Intl. · May 1994
EXERCISE BICYCLE
K926287 · Henley Intl. · Mar 1994
HYDRA FITNESS MODEL 311 TOTAL POWER
K926314 · Henley Intl. · Mar 1994
CABLE COLUMN WEIGHT SYSTEM MODEL #940-200
K922602 · Biodan Medical Systems, Ltd. · Jun 1992
TOTAL WORK INTEGRATOR, MODEL #940-110
K922603 · Biodan Medical Systems, Ltd. · Jun 1992
MULTI JOINT WEIGHT SYSTEM MODEL #940-100
K922606 · Biodan Medical Systems, Ltd. · Jun 1992