Cleared Traditional

K071710 - BENGAY HEAT THERAPY

K071710 is the FDA 510(k) clearance for BENGAY HEAT THERAPY by Johnson & Johnson Consumer Products, Inc.. It is a Class 1 Physical Medicine device (product code IMD) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K071710 · Johnson & Johnson Consumer Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
53d
Days
Class 1
Risk

K071710 is an FDA 510(k) clearance for the BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS). Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Johnson & Johnson Consumer Products, Inc. (Morris Plains, US). The FDA issued a Cleared decision on August 14, 2007 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - 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 Johnson & Johnson Consumer Products, Inc. devices

Submission Details

510(k) Number K071710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2007
Decision Date August 14, 2007
Days to Decision 53 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
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 - IMD Pack, Hot Or Cold, Disposable

All 20
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