Cleared Traditional

PARKER MODEL PE (K950377) - FDA 510(k) Clearance

Class I Physical Medicine device.

K950377 · Parker Treadmill Co., Inc. · Physical Medicine device
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Sep 1995
Decision
218d
Days
Class 1
Risk

K950377 is an FDA 510(k) clearance for the PARKER MODEL PE. Classified as Treadmill, Powered (product code IOL), Class I - General Controls.

Submitted by Parker Treadmill Co., Inc. (Auburn, US). The FDA issued a Cleared decision on September 6, 1995 after a review of 218 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 Parker Treadmill Co., Inc. devices

Submission Details

510(k) Number K950377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date September 06, 1995
Days to Decision 218 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
103d slower than avg
Panel avg: 115d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IOL Treadmill, 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.