Cleared Traditional

K950376 - PARKER MODEL PM

K950376 is an FDA 510(k) clearance for PARKER MODEL PM, manufactured by Parker Treadmill Co., Inc.. The device is a Class 1 Physical Medicine device with product code IOL cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K950376 · Parker Treadmill Co., Inc. · Physical Medicine device
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Sep 1995
Decision
218d
Days
Class 1
Risk

K950376 is an FDA 510(k) clearance for the PARKER MODEL PM. 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

FDA 510(k) Submission Details - K950376

510(k) Number K950376 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.

IOL Device Classification - Class 1, General Controls

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.

Regulatory Peers - IOL Treadmill, Powered

All 22
Devices cleared under the same product code (IOL) and FDA review panel - the closest regulatory comparables to K950376.
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K863299 · Quinton, Inc. · Sep 1986