Cleared Traditional

K830875 - S & W MODEL 29

K830875 is the FDA 510(k) clearance for S & W MODEL 29 by S & W Enterprises, Inc.. It is a Class 2 Physical Medicine device (product code JFB) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K830875 · S & W Enterprises, Inc. · Physical Medicine device
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Apr 1983
Decision
21d
Days
Class 2
Risk

K830875 is an FDA 510(k) clearance for the S & W MODEL 29. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by S & W Enterprises, Inc. (Walker, US). The FDA issued a Cleared decision on April 8, 1983 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - 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 K830875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1983
Decision Date April 08, 1983
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.