Cleared Traditional

K831699 - STRESS MACHINE

K831699 is the FDA 510(k) clearance for STRESS MACHINE by Dr. William F. Curran. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831699 · Dr. William F. Curran · Physical Medicine device
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Jul 1983
Decision
48d
Days
Class 1
Risk

K831699 is an FDA 510(k) clearance for the STRESS MACHINE. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Dr. William F. Curran (Walker, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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 Dr. William F. Curran devices

Submission Details

510(k) Number K831699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1983
Decision Date July 12, 1983
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
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.