Cleared Traditional

ARTROMOT K2 CPM (K931555) - FDA 510(k) Clearance

Class I Physical Medicine device.

K931555 · Ormed Mfg., Inc. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Jan 1994
Decision
307d
Days
Class 1
Risk

K931555 is an FDA 510(k) clearance for the ARTROMOT K2 CPM. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Ormed Mfg., Inc. (Concord, US). The FDA issued a Cleared decision on January 31, 1994 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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.

View all Ormed Mfg., Inc. devices

Submission Details

510(k) Number K931555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date January 31, 1994
Days to Decision 307 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
192d slower than avg
Panel avg: 115d · This submission: 307d
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.