PT-PAC PORTABLE HEATING PAD

K963887 · Anthony A. Chiurco · IRT · Mar 31, 1997 · Physical Medicine

Device Facts

• Record ID: K963887
• Device Name: PT-PAC PORTABLE HEATING PAD
• Applicant: Anthony A. Chiurco
• Product Code: IRT · Physical Medicine
• Decision Date: Mar 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PT-Pac is a portable heating pad. It is a non-significant risk device similar to predicate devices (powered heating pads 890.5740) in providing sustained electrical powered heat to a defined body region.

Device Story

Portable heating pad; provides sustained heat to body regions; utilizes thermoelectric tiles for heat transfer; powered by low-voltage DC batteries; microprocessor-controlled temperature regulation; includes dual safety circuits; biocompatible 100% cotton cover; intended for use by patients; provides soothing warmth; safer and more portable than AC-powered heating pads.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Thermoelectric tiles; low-voltage DC battery power; microprocessor-controlled; 100% cotton cover; dual safety circuits; portable form factor.

Indications for Use

Indicated for providing sustained electrical powered heat to a defined body region for therapeutic warmth.

Regulatory Classification

Identification

A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.

Predicate Devices

• powered heating pads (890.5740)

Submission Summary (Full Text)

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October 11, 1996
510(k) number: 1963887
PT-Pac Portable Heating Pad
MAR 31 1997

# 510(k) SUMMARY:

The PT-Pac is a portable heating pad. It is a non-significant risk device similar to predicate devices (powered heating pads 890.5740) in providing sustained electrical powered heat to a defined body region. As with approved heating pads, the skin contacts only a biocompatible (100% cotton) cover. The PT-Pac claims the ability to provide soothing warmth in the temperature range of predicate devices. PT-Pac differs from alternating current powered devices in that it is powered by low-voltage, direct-current batteries, making it portable as well as safer than conventional heating pads. The PT-Pac uses highly reliable thermoelectric tiles to transfer heat. These are microprocessor-controlled, providing strict temperature regulation. The redundancy of two safety circuits, together with the finite time that the batteries can power the unit, make the safety of this device more robust than that of predicate devices.