Cleared Traditional

K931640 - AO11 BODY MASSAGER

K931640 is an FDA 510(k) clearance for AO11 BODY MASSAGER, manufactured by Fairform Mfg., Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 362-day FDA review.

K931640 · Fairform Mfg., Co., Ltd. · Physical Medicine device
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Mar 1994
Decision
362d
Days
Class 1
Risk

K931640 is an FDA 510(k) clearance for the AO11 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 March 28, 1994 after a review of 362 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

FDA 510(k) Submission Details - K931640

510(k) Number K931640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1993
Decision Date March 28, 1994
Days to Decision 362 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
247d slower than avg
Panel avg: 115d · This submission: 362d
Pathway characteristics
Predicate-based equivalence.

IRO Device Classification - Class 1, General Controls

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 22
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K931640.
CONAIR FAMILY FITNESS BODY ENERGY
K950441 · Conair Corp. · Jul 1995
CONAIR BODY AND SOLE
K950410 · Conair Corp. · May 1995
SQUEEZE PLAY
K943730 · Conair Corp. · Nov 1994
SONASSAGE
K923238 · Conair Corp. · Feb 1994
CARAPACE SUTURE REMOVAL TRAYS
K931819 · Carapace, Inc. · Jan 1994
HEALTLH ESSENTIALS PERSONAL MASSAGER
K924431 · Conair Corp. · Oct 1993