Cleared Traditional

K801643 - TRITON (FDA 510(k) Clearance)

Class I Physical Medicine device.

K801643 · Chattanooga Group, Inc. · Physical Medicine device
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Jul 1980
Decision
11d
Days
Class 1
Risk

K801643 is an FDA 510(k) clearance for the TRITON. Classified as Table, Mechanical (product code INW), Class I - General Controls.

Submitted by Chattanooga Group, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3750 - 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 Chattanooga Group, Inc. devices

Submission Details

510(k) Number K801643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1980
Decision Date July 28, 1980
Days to Decision 11 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
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INW Table, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3750
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.