Cleared Traditional

COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER (K955160) - FDA 510(k) Clearance

Class I Physical Medicine device.

K955160 · Everapex Design & Marketing Corp. · Physical Medicine device

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Feb 1996

Decision

87d

Days

Class 1

Risk

K955160 is an FDA 510(k) clearance for the COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Everapex Design & Marketing Corp. (Taipei, TW). The FDA issued a Cleared decision on February 8, 1996 after a review of 87 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 Everapex Design & Marketing Corp. devices

Submission Details

510(k) Number	K955160 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	November 13, 1995
Decision Date	February 08, 1996
Days to Decision	87 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

28d faster than avg

Panel avg: 115d · This submission: 87d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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 64

Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K955160.

VARIABLE SPEED VIBRATOR, 120V 83-117 VIB

K821633 · Fred Sammons, Inc. · Jun 1982

VIBRATOR

K810446 · Fred Sammons, Inc. · Mar 1981

BK-5203 FACILITATION VIBRATOR ELECTRIC

K800018 · Fred Sammons, Inc. · Jan 1980

HEAD FACILITATION VIBRATOR BK-5210

K771279 · Fred Sammons, Inc. · Aug 1977

ELECTRIC VIBRATOR

K761121 · Fred Sammons, Inc. · Dec 1976

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K955160

Everapex Design & Marketing Corp.

Taipei · TW

PETER LIAO

Regulatory profile

1 submissions 0 cleared

0% clearance rate · Active in Physical Medicine

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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