Cleared Traditional

K893032 - PACER R 9 TREADMILL

K893032 is an FDA 510(k) clearance for PACER R 9 TREADMILL, manufactured by Pacer Industries, Inc.. The device is a Class 1 Physical Medicine device with product code IOL cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K893032 · Pacer Industries, Inc. · Physical Medicine device
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Jul 1989
Decision
94d
Days
Class 1
Risk

K893032 is an FDA 510(k) clearance for the PACER R 9 TREADMILL. Classified as Treadmill, Powered (product code IOL), Class I - General Controls.

Submitted by Pacer Industries, Inc. (Carrollton, US). The FDA issued a Cleared decision on July 27, 1989 after a review of 94 days - within the typical 510(k) review window.

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 Pacer Industries, Inc. devices

FDA 510(k) Submission Details - K893032

510(k) Number K893032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1989
Decision Date July 27, 1989
Days to Decision 94 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
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 K893032.
RTM REHABILITATION TREADMILL, MODEL #945-200
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MODIFIED Q50 MEDICAL TREADMILL
K863299 · Quinton, Inc. · Sep 1986