Cleared Traditional

K910519 - GOOD VIBRATIONS TUBE MASSAGER

K910519 is an FDA 510(k) clearance for GOOD VIBRATIONS TUBE MASSAGER, manufactured by Dual Voltage, Inc.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K910519 · Dual Voltage, Inc. · Physical Medicine device
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Apr 1991
Decision
53d
Days
Class 1
Risk

K910519 is an FDA 510(k) clearance for the GOOD VIBRATIONS TUBE MASSAGER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Dual Voltage, Inc. (Grand Prairie, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 53 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 Dual Voltage, Inc. devices

FDA 510(k) Submission Details - K910519

510(k) Number K910519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1991
Decision Date April 01, 1991
Days to Decision 53 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
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

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

All 28
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K910519.
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