Cleared Traditional

K041200 - THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000

K041200 is an FDA 510(k) clearance for THERMASSAGE ENEGRY PRODUCT, manufactured by Migun Medical Instrument Co. , Ltd.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K041200 · Migun Medical Instrument Co. , Ltd. · Physical Medicine device
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Jun 2004
Decision
41d
Days
Class 2
Risk

K041200 is an FDA 510(k) clearance for the THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Migun Medical Instrument Co. , Ltd. (Cleveland, US). The FDA issued a Cleared decision on June 17, 2004 after a review of 41 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.

FDA 510(k) Submission Details - K041200

510(k) Number K041200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2004
Decision Date June 17, 2004
Days to Decision 41 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
75d faster than avg
Panel avg: 116d · This submission: 41d
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 K041200.
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MAGNUM
K010252 · Magnum Equipment LLC · Apr 2001
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
K002390 · Lsi Intl., Inc. · Nov 2000
K041200 · THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
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