Cleared Traditional

FO41 BODY MASSAGER (K914705) - FDA 510(k) Clearance

Class I Physical Medicine device.

K914705 · Fairform Mfg., Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
52d
Days
Class 1
Risk

K914705 is an FDA 510(k) clearance for the FO41 BODY MASSAGER. 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 December 9, 1991 after a review of 52 days - a notably fast clearance cycle.

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: 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 Fairform Mfg., Co., Ltd. devices

Submission Details

510(k) Number K914705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1991
Decision Date December 09, 1991
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 K914705.
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
K821633 · Fred Sammons, Inc. · Jun 1982
VIBRATOR
K810446 · Fred Sammons, Inc. · Mar 1981
BK-5203 FACILITATION VIBRATOR ELECTRIC
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