Cleared Traditional

PROGRAM. TREADMILL CONTROLLER #645 (K830146) - FDA 510(k) Clearance

Class I Physical Medicine device.

K830146 · Quinton, Inc. · Physical Medicine device

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Feb 1983

Decision

16d

Days

Class 1

Risk

K830146 is an FDA 510(k) clearance for the PROGRAM. TREADMILL CONTROLLER #645. Classified as Treadmill, Powered (product code IOL), Class I - General Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 2, 1983 after a review of 16 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quinton, Inc. devices

Submission Details

510(k) Number	K830146 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 17, 1983
Decision Date	February 02, 1983
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

99d faster than avg

Panel avg: 115d · This submission: 16d

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.

Regulatory Peers - IOL Treadmill, Powered

All 9

Devices cleared under the same product code (IOL) and FDA review panel - the closest regulatory comparables to K830146.

MODEL Q55XT POWERED TREADMILL

K864013 · Quinton, Inc. · Nov 1986

MODIFIED Q50 MEDICAL TREADMILL

K863299 · Quinton, Inc. · Sep 1986

Q50 MEDICAL TREADMILL

K862741 · Quinton, Inc. · Jul 1986

Q65 MEDICAL TREADMILL

K823003 · Quinton, Inc. · Oct 1982

QUINTON Q55 MEDICAL TREADMILL

K820478 · Quinton, Inc. · Mar 1982

CARDIO-EXERCISE TREADMILL 550

K771697 · Quinton, Inc. · Sep 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K830146

Quinton, Inc.

Mchenry, IL · US

Regulatory profile

164 submissions 160 cleared

98% clearance rate · Active in Physical Medicine

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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