Cleared Traditional

K051961 - WWMED, MODEL 401

K051961 is an FDA 510(k) clearance for WWMED, manufactured by Wong Way Corporation. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K051961 · Wong Way Corporation · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
206d
Days
Class 2
Risk

K051961 is an FDA 510(k) clearance for the WWMED, MODEL 401. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Wong Way Corporation (Stamford, US). The FDA issued a Cleared decision on February 10, 2006 after a review of 206 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - 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 - K051961

510(k) Number K051961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2005
Decision Date February 10, 2006
Days to Decision 206 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 116d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 - ILY Lamp, Infrared, Therapeutic Heating

All 227
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K051961.
APOLLO IR HEAT LAMP SYSTEM
K060134 · Apollo Physical Therapy Products International · Mar 2006
BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS
K051875 · Meditech International, Inc. · Mar 2006
CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810
K053376 · Chung Cheng Electric Heating Co., Ltd. · Feb 2006
MAESTRO MDTL LASER SYSTEM
K053473 · Advanced Medical Technologies, Inc. · Feb 2006
BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM
K052307 · Beamline Corporation · Dec 2005
CURAE'LASE CL1000 IR LASER SYSTEM
K053201 · Curae'Lase, Inc. · Dec 2005
K051961 · WWMED, MODEL 401
Download PDF FDA Summary Wong Way Corporation