Cleared Traditional

K913439 - SONIX...THERAPEUTIC SONIC MASSAGE

K913439 is an FDA 510(k) clearance for SONIX...THERAPEUTIC SONIC MASSAGE, manufactured by Mcshirley Products, Inc.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K913439 · Mcshirley Products, Inc. · Physical Medicine device
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Jan 1992
Decision
173d
Days
Class 1
Risk

K913439 is an FDA 510(k) clearance for the SONIX...THERAPEUTIC SONIC MASSAGE. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Mcshirley Products, Inc. (Valencia, US). The FDA issued a Cleared decision on January 22, 1992 after a review of 173 days - an extended review 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: 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 Mcshirley Products, Inc. devices

FDA 510(k) Submission Details - K913439

510(k) Number K913439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1991
Decision Date January 22, 1992
Days to Decision 173 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
58d slower than avg
Panel avg: 115d · This submission: 173d
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 K913439.
HEALTH ESSENTIALS BODY CARE MASSAGER
K924582 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER
K924583 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS FANCY PERSONAL MASSAGER
K924584 · Conair Corp. · Oct 1993
PAM PLUS
K913998 · Kinetic Concepts, Inc. · Jan 1992
TOUCH N TONE 1 MASSAGER
K915242 · Conair Corp. · Dec 1991
MULTI-REACH II WAND MASSAGER
K914344 · Conair Corp. · Oct 1991