Cleared Traditional

K831394 - SOMATRON

K831394 is an FDA 510(k) clearance for SOMATRON, manufactured by Somatron Co.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K831394 · Somatron Co. · Physical Medicine device
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Jun 1983
Decision
40d
Days
Class 2
Risk

K831394 is an FDA 510(k) clearance for the SOMATRON. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Somatron Co. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 40 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.

FDA 510(k) Submission Details - K831394

510(k) Number K831394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1983
Decision Date June 08, 1983
Days to Decision 40 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
76d faster than avg
Panel avg: 116d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JFB Table, Physical Therapy, Multi Function

All 65
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K831394.
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K822413 · Medical Management Service, Inc. · Jun 1983
S & W MODEL 29
K830875 · S & W Enterprises, Inc. · Apr 1983
ACU-MASSAGE TABLE
K822693 · H.W.E., Inc. · Sep 1982
K831394 · SOMATRON
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