Cleared Traditional

K854194 - IMT ULTRASONIC STRIDE MONITOR

K854194 · Innovative Medical Technologies, Inc. · Physical Medicine device
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May 1986
Decision
199d
Days
-
Risk

K854194 is an FDA 510(k) clearance for the IMT ULTRASONIC STRIDE MONITOR.

Submitted by Innovative Medical Technologies, Inc. (Chicago, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 199 days - an extended review cycle.

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 Innovative Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K854194

510(k) Number K854194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date May 02, 1986
Days to Decision 199 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
84d slower than avg
Panel avg: 115d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -