Cleared Traditional

K903617 - MUSCLE MASSAGER

K903617 is an FDA 510(k) clearance for MUSCLE MASSAGER, manufactured by Uri Halfon and Gabriel Hertzberg. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K903617 · Uri Halfon and Gabriel Hertzberg · Physical Medicine device
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Nov 1990
Decision
110d
Days
Class 1
Risk

K903617 is an FDA 510(k) clearance for the MUSCLE MASSAGER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Uri Halfon and Gabriel Hertzberg (Beverly Hills, US). The FDA issued a Cleared decision on November 26, 1990 after a review of 110 days - within the typical 510(k) review window.

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: 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 Uri Halfon and Gabriel Hertzberg devices

FDA 510(k) Submission Details - K903617

510(k) Number K903617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1990
Decision Date November 26, 1990
Days to Decision 110 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
5d faster than avg
Panel avg: 115d · This submission: 110d
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 K903617.
BODY SOOTHER
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VACOMED 4
K842802 · Robert Bosch Corp. · Aug 1984
SENSORY ROLLER MASSAGER
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MAGIC CUSHION MASSAGER
K810447 · Fred Sammons, Inc. · Mar 1981