Cleared Traditional

K053285 - MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM

K053285 is an FDA 510(k) clearance for MAGBODY DT-1200, manufactured by Durtech System Corp.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K053285 · Durtech System Corp. · Physical Medicine device
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Jan 2006
Decision
41d
Days
Class 2
Risk

K053285 is an FDA 510(k) clearance for the MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Durtech System Corp. (His-Chih Taipei, TW). The FDA issued a Cleared decision on January 5, 2006 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 890.5850 - 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 - K053285

510(k) Number K053285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2005
Decision Date January 05, 2006
Days to Decision 41 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
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. Third-party reviewed.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Consultant

Underwriters Laboratories, Inc.
MARC M MOUSER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 490
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K053285.
VITALSTIM EXPERIA
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K062354 · Encore Medical, L.P. · Jan 2007
MYOTRAC INFINITI
K053266 · Thought Technology , Ltd. · Dec 2005
EASYSTIM NMS-28
K050921 · Easy Med Instrument Co., Ltd. · Dec 2005
AXIOM NVP8500
K051135 · Axiom Worldwide, Inc. · Aug 2005

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K053285 · MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM
Download PDF Durtech System Corp.