Cleared Traditional

K821109 - TRIMMORE ELECTION BEAUTIFIER

K821109 is an FDA 510(k) clearance for TRIMMORE ELECTION BEAUTIFIER, manufactured by Rn Int'L, Inc.. The device is a Class 1 Physical Medicine device with 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.

FDA 510(k) Submission Details - K821109

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 116d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

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.

Regulatory Peers - ISA Massager, Therapeutic, Electric

All 96
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K821109.
STRESS MACHINE
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K823927 · New Age Corp. · Feb 1983
SOFT & STROKE
K811782 · Phoenix Intl. Marketing, Inc. · Jul 1981
NORELCO MASSAGER PLUS HEAT BELT
K811891 · North American Philips Corp. · Jul 1981
MAGIC CUSHION MASSAGER
K810447 · Fred Sammons, Inc. · Mar 1981
K821109 · TRIMMORE ELECTION BEAUTIFIER
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