Cleared Traditional

S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS (K864817) - FDA 510(k) Clearance

Class I Physical Medicine device.

K864817 · S & W Enterprises, Inc. · Physical Medicine device
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Jan 1987
Decision
27d
Days
Class 1
Risk

K864817 is an FDA 510(k) clearance for the S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by S & W Enterprises, Inc. (Blaine, US). The FDA issued a Cleared decision on January 5, 1987 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - 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 S & W Enterprises, Inc. devices

Submission Details

510(k) Number K864817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date January 05, 1987
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
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.