Cleared Traditional

MANUAL MASSAGE ROLLER (K936312) - FDA 510(k) Clearance

Class I Physical Medicine device.

K936312 · Mckenna & Cuneo · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
794d
Days
Class 1
Risk

K936312 is an FDA 510(k) clearance for the MANUAL MASSAGE ROLLER. Classified as Massager, Therapeutic, Manual (product code LYG), Class I - General Controls.

Submitted by Mckenna & Cuneo (Washington, US). The FDA issued a Cleared decision on January 29, 1996 after a review of 794 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Mckenna & Cuneo devices

Submission Details

510(k) Number K936312 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 26, 1993
Decision Date January 29, 1996
Days to Decision 794 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
679d slower than avg
Panel avg: 115d · This submission: 794d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYG Massager, Therapeutic, Manual
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.