Cleared Traditional

F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR (K931639) - FDA 510(k) Clearance

Class I Physical Medicine device.

K931639 · Fairform Mfg., Co., Ltd. · Physical Medicine device
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Mar 1994
Decision
363d
Days
Class 1
Risk

K931639 is an FDA 510(k) clearance for the F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Fairform Mfg., Co., Ltd. (San Po Kong, Kowloon, HK). The FDA issued a Cleared decision on March 28, 1994 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - 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. Elevated predicate reliance profile. 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 Fairform Mfg., Co., Ltd. devices

Submission Details

510(k) Number K931639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date March 28, 1994
Days to Decision 363 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 115d · This submission: 363d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
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 - IRO Vibrator, Therapeutic

All 64
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K931639.
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VIBRATOR
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K800018 · Fred Sammons, Inc. · Jan 1980
HEAD FACILITATION VIBRATOR BK-5210
K771279 · Fred Sammons, Inc. · Aug 1977
ELECTRIC VIBRATOR
K761121 · Fred Sammons, Inc. · Dec 1976