Cleared Traditional

K821109 - TRIMMORE ELECTION BEAUTIFIER

K821109 is the FDA 510(k) clearance for TRIMMORE ELECTION BEAUTIFIER by Rn Int'L, Inc.. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K821109 · Rn Int'L, Inc. · Physical Medicine device
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Aug 1982
Decision
133d
Days
Class 1
Risk

K821109 is an FDA 510(k) clearance for the TRIMMORE ELECTION BEAUTIFIER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Rn Int'L, Inc. (Walker, US). The FDA issued a Cleared decision on August 31, 1982 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Rn Int'L, Inc. devices

Submission Details

510(k) Number K821109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1982
Decision Date August 31, 1982
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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.