Cleared Traditional

K950400 - HAND MASSAGE UNIT

K950400 is an FDA 510(k) clearance for HAND MASSAGE UNIT, manufactured by Ultrassage, Inc.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K950400 · Ultrassage, Inc. · Physical Medicine device
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Mar 1995
Decision
57d
Days
Class 1
Risk

K950400 is an FDA 510(k) clearance for the HAND MASSAGE UNIT. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Ultrassage, Inc. (Ville Mont-Royal, Quebec, CA). The FDA issued a Cleared decision on March 30, 1995 after a review of 57 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 Ultrassage, Inc. devices

FDA 510(k) Submission Details - K950400

510(k) Number K950400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1995
Decision Date March 30, 1995
Days to Decision 57 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 faster than avg
Panel avg: 115d · This submission: 57d
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 K950400.
QI GONG MASSAGER
K955250 · East Health Development Group, Inc. · Feb 1996
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