Cleared Traditional

ACTIC 2002 (K946169) - FDA 510(k) Clearance

Class I Physical Medicine device.

K946169 · North Atlantic Rehabilitation, Inc. · Physical Medicine device
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Jun 1995
Decision
178d
Days
Class 1
Risk

K946169 is an FDA 510(k) clearance for the ACTIC 2002. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by North Atlantic Rehabilitation, Inc. (West Bend, US). The FDA issued a Cleared decision on June 15, 1995 after a review of 178 days - an extended review 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: 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 North Atlantic Rehabilitation, Inc. devices

Submission Details

510(k) Number K946169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1994
Decision Date June 15, 1995
Days to Decision 178 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
63d slower than avg
Panel avg: 115d · This submission: 178d
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.