Cleared Traditional

K850870 - MEDIFETTE ERGOMETER

K850870 · Ketronic, Inc. · Physical Medicine device
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Jun 1985
Decision
103d
Days
-
Risk

K850870 is an FDA 510(k) clearance for the MEDIFETTE ERGOMETER.

Submitted by Ketronic, Inc. (The Netherlands, NL). The FDA issued a Cleared decision on June 12, 1985 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel. 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 Ketronic, Inc. devices

FDA 510(k) Submission Details - K850870

510(k) Number K850870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date June 12, 1985
Days to Decision 103 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -