Cleared Traditional

MUSCLE MASSAGER (K903617) - FDA 510(k) Clearance

Class I Physical Medicine device.

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

Submission Details

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.

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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