Cleared Traditional

K040031 - CERAGEM-C THERMAL ACUPRESSURE MASSAGER

K040031 is an FDA 510(k) clearance for CERAGEM-C THERMAL ACUPRESSURE MASSAGER, manufactured by Ceragem Co., Ltd.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K040031 · Ceragem Co., Ltd. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
202d
Days
Class 2
Risk

K040031 is an FDA 510(k) clearance for the CERAGEM-C THERMAL ACUPRESSURE MASSAGER. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Ceragem Co., Ltd. (Washington, US). The FDA issued a Cleared decision on July 28, 2004 after a review of 202 days - an extended review 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: 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 Ceragem Co., Ltd. devices

FDA 510(k) Submission Details - K040031

510(k) Number K040031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2004
Decision Date July 28, 2004
Days to Decision 202 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
86d slower than avg
Panel avg: 116d · This submission: 202d
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 38
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K040031.
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MAGNUM
K010252 · Magnum Equipment LLC · Apr 2001
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K002390 · Lsi Intl., Inc. · Nov 2000