Cleared Traditional

K062476 - CERAGEM RH1 AUTOMATIC THERMAL MASSAGER

K062476 is an FDA 510(k) clearance for CERAGEM RH1 AUTOMATIC THERMAL MASSAGER, manufactured by Ceragem International, Inc.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K062476 · Ceragem International, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
68d
Days
Class 2
Risk

K062476 is an FDA 510(k) clearance for the CERAGEM RH1 AUTOMATIC THERMAL MASSAGER. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Ceragem International, Inc. (Washington, US). The FDA issued a Cleared decision on October 31, 2006 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - 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 Ceragem International, Inc. devices

FDA 510(k) Submission Details - K062476

510(k) Number K062476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date October 31, 2006
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFB Device Classification - Class 2, Special Controls

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - JFB Table, Physical Therapy, Multi Function

All 17
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K062476.
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