Cleared Traditional

THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES (K950655) - FDA 510(k) Clearance

Class I Physical Medicine device.

K950655 · Ultrassage, Inc. · Physical Medicine device
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Mar 1995
Decision
34d
Days
Class 1
Risk

K950655 is an FDA 510(k) clearance for the THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Ultrassage, Inc. (Ville Mont-Royal, Quebec, CA). The FDA issued a Cleared decision on March 7, 1995 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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

Submission Details

510(k) Number K950655 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 01, 1995
Decision Date March 07, 1995
Days to Decision 34 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
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 - ISA Massager, Therapeutic, Electric

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