Cleared Traditional

BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM (K883198) - FDA 510(k) Clearance

Class I Physical Medicine device.

K883198 · Advanced Mechanical Technology, Inc. · Physical Medicine device
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Oct 1988
Decision
88d
Days
Class 1
Risk

K883198 is an FDA 510(k) clearance for the BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM. 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 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Mechanical Technology, Inc. devices

Submission Details

510(k) Number K883198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date October 24, 1988
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.