Cleared Traditional

K831206 - ARUBI FLATTER & ARUBI FLATTER-S

K831206 is the FDA 510(k) clearance for ARUBI FLATTER & ARUBI FLATTER-S by Kc Export Management Co.. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K831206 · Kc Export Management Co. · Physical Medicine device
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Jun 1983
Decision
50d
Days
Class 1
Risk

K831206 is an FDA 510(k) clearance for the ARUBI FLATTER & ARUBI FLATTER-S. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Kc Export Management Co. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 50 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 Kc Export Management Co. devices

Submission Details

510(k) Number K831206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1983
Decision Date June 02, 1983
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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.