Cleared Traditional

K010252 - MAGNUM

K010252 is an FDA 510(k) clearance for MAGNUM, manufactured by Magnum Equipment LLC. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010252 · Magnum Equipment LLC · Physical Medicine device
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Apr 2001
Decision
90d
Days
Class 2
Risk

K010252 is an FDA 510(k) clearance for the MAGNUM. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Magnum Equipment LLC (Oklahoma City, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 90 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K010252

510(k) Number K010252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2001
Decision Date April 26, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 116d · This submission: 90d
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 65
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K010252.
CERAGEM-C THERMAL ACUPRESSURE MASSAGER
K040031 · Ceragem Co., Ltd. · Jul 2004
THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
K041200 · Migun Medical Instrument Co. , Ltd. · Jun 2004
THERMASSAGE ENERGY PRODUCT, MODEL HY5000
K032449 · Migun Medical Instrument Co. , Ltd. · Oct 2003
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
K002390 · Lsi Intl., Inc. · Nov 2000
QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
K993461 · Icon Intl., LLC · Jan 2000
EXTENTRAC
K980021 · Advanced Back Technologies · May 1998
K010252 · MAGNUM
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