Cleared Traditional

K963824 - LI'S ITCH STOPPER

K963824 is an FDA 510(k) clearance for LI'S ITCH STOPPER, manufactured by Hontech Foundation For Medical Technology. The device is a Class 2 Physical Medicine device with product code IRT cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K963824 · Hontech Foundation For Medical Technology · Physical Medicine device
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Dec 1996
Decision
80d
Days
Class 2
Risk

K963824 is an FDA 510(k) clearance for the LI'S ITCH STOPPER. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Hontech Foundation For Medical Technology (Cambridge, US). The FDA issued a Cleared decision on December 12, 1996 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - 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 Hontech Foundation For Medical Technology devices

FDA 510(k) Submission Details - K963824

510(k) Number K963824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1996
Decision Date December 12, 1996
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRT Device Classification - Class 2, Special Controls

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
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 - IRT Pad, Heating, Powered

All 20
Devices cleared under the same product code (IRT) and FDA review panel - the closest regulatory comparables to K963824.
FIR HEAT THERAPHY SYSYEMS
K111273 · Shenzhen Anpan Technology Co., Ltd. · Nov 2011
BIO-MAT 2000
K072534 · Richway Intl., Inc. · Feb 2008
PT-PAC PORTABLE HEATING PAD
K963887 · Anthony A. Chiurco · Mar 1997
HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3
K962195 · Sunbeam Health Division · Nov 1996
HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4
K962252 · Sunbeam Health Division · Nov 1996
PES HOT/COLD COMPRESS
K962038 · Princeton Electronic Systems, Inc. · Nov 1996