Cleared Traditional

K883131 - BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000

K883131 is an FDA 510(k) clearance for BIOMECHANICS FORCE PLATFORM #LG6-4-1000..., manufactured by Advanced Mechanical Technology, Inc.. The device is a Class 1 Physical Medicine device with product code KHX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K883131 · Advanced Mechanical Technology, Inc. · Physical Medicine device
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Oct 1988
Decision
90d
Days
Class 1
Risk

K883131 is an FDA 510(k) clearance for the BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000. Classified as Platform, Force-measuring (product code KHX), Class I - General Controls.

Submitted by Advanced Mechanical Technology, Inc. (Newton, US). The FDA issued a Cleared decision on October 24, 1988 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1575 - 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 Advanced Mechanical Technology, Inc. devices

FDA 510(k) Submission Details - K883131

510(k) Number K883131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date October 24, 1988
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

KHX Device Classification - Class 1, General Controls

Product Code KHX Platform, Force-measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1575
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.