Cleared Traditional

K963887 - PT-PAC PORTABLE HEATING PAD

K963887 is an FDA 510(k) clearance for PT-PAC PORTABLE HEATING PAD, manufactured by Anthony A. Chiurco. The device is a Class 2 Physical Medicine device with product code IRT cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K963887 · Anthony A. Chiurco · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
186d
Days
Class 2
Risk

K963887 is an FDA 510(k) clearance for the PT-PAC PORTABLE HEATING PAD. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Anthony A. Chiurco (Levitown Road, US). The FDA issued a Cleared decision on March 31, 1997 after a review of 186 days - an extended review 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: 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.

View all Anthony A. Chiurco devices

FDA 510(k) Submission Details - K963887

510(k) Number K963887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1996
Decision Date March 31, 1997
Days to Decision 186 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
71d slower than avg
Panel avg: 115d · This submission: 186d
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 K963887.
AVACEN 100
K133981 · Avacen, Inc. · Aug 2014
FIR HEAT THERAPHY SYSYEMS
K111273 · Shenzhen Anpan Technology Co., Ltd. · Nov 2011
BIO-MAT 2000
K072534 · Richway Intl., Inc. · Feb 2008
LI'S ITCH STOPPER
K963824 · Hontech Foundation For Medical Technology · Dec 1996
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