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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Migun Medical Instrument Co. , Ltd. devices

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
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · 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 27
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K041200.
CHOYANG THERMAL MASSAGER
K111941 · Choyang Medical Instrument Co., Ltd. · May 2012
NM-7000
K111329 · Nuga Medical Co., Ltd. · Sep 2011
AIR-FLEX WITH AUTO-DISTRACTION
K063034 · Hill Laboratories Co. · Dec 2006
QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
K993461 · Icon Intl., LLC · Jan 2000
EXTENTRAC
K980021 · Advanced Back Technologies · May 1998
P.T. MACHINE
K974626 · Goodman, Goodman & Goodman · Feb 1998