Cleared Traditional

FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01 (K940085) - FDA 510(k) Clearance

K940085 · Sense Technology, Inc. · Physical Medicine device
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Dec 1994
Decision
334d
Days
-
Risk

K940085 is an FDA 510(k) clearance for the FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Sense Technology, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on December 7, 1994 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K940085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1994
Decision Date December 07, 1994
Days to Decision 334 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
219d slower than avg
Panel avg: 115d · This submission: 334d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXM Manipulator, Plunger-like Joint
Device Class -