Cleared Traditional

K854194 - IMT ULTRASONIC STRIDE MONITOR (FDA 510(k) Clearance)

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

Submission Details

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

Product Code -
Device Class -