Cleared Traditional

K130631 - BUZZY (FDA 510(k) Clearance)

Class I Physical Medicine device.

K130631 · Mmj Labs, LLC · Physical Medicine device
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Aug 2014
Decision
523d
Days
Class 1
Risk

K130631 is an FDA 510(k) clearance for the BUZZY. Classified as Cold Pack And Vibrating Massager (product code PHW), Class I - General Controls.

Submitted by Mmj Labs, LLC (Atlanta, US). The FDA issued a Cleared decision on August 13, 2014 after a review of 523 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - 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: 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 Mmj Labs, LLC devices

Submission Details

510(k) Number K130631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2013
Decision Date August 13, 2014
Days to Decision 523 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
408d slower than avg
Panel avg: 115d · This submission: 523d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PHW Cold Pack And Vibrating Massager
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
Definition Relief Of Minor Aches And Pains, Controlling The Pain Associated With Needle Sticks (injections, Iv, Venipuncture).
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.