Cleared Traditional

JACE KNEE EXTENSION SYSTEM -- MODIFICATION (K922185) - FDA 510(k) Clearance

Class I Physical Medicine device.

K922185 · Jace Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
35d
Days
Class 1
Risk

K922185 is an FDA 510(k) clearance for the JACE KNEE EXTENSION SYSTEM -- MODIFICATION. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Jace Systems, Inc. (Moorestown, US). The FDA issued a Cleared decision on June 11, 1992 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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 Jace Systems, Inc. devices

Submission Details

510(k) Number K922185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1992
Decision Date June 11, 1992
Days to Decision 35 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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.