EBI THERMAL THERAPY SYSTEM

K963261 · Electro-Biology, Inc. · ILO · Sep 27, 1996 · Physical Medicine

Device Facts

• Record ID: K963261
• Device Name: EBI THERMAL THERAPY SYSTEM
• Applicant: Electro-Biology, Inc.
• Product Code: ILO · Physical Medicine
• Decision Date: Sep 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The EBI Thermal Therapy System is intended to apply localized cold or heat therapy to body surfaces. The EBI Thermal Therapy System is designed to lower or raise the surface skin temperature by delivering water at a controlled temperature to the target site via a thermal pad. The system is designed for repeated uses in the hospital or home. The thermal pad is designed for single patient use.

Device Story

System delivers temperature-controlled water to target body sites via thermal pads; consists of water delivery unit (pump, reservoir, heat exchangers, electronic control module, display, keypad) and insulated hoses. Used in hospital or home settings; operated by clinicians or patients. Provides localized thermal therapy to modulate skin temperature. Output is physical thermal energy; healthcare providers use to manage localized temperature for therapeutic purposes.

Clinical Evidence

Bench testing only; comparative performance testing against Danninger Thermal-Max Thermal Therapy Unit demonstrated equivalent performance characteristics.

Technological Characteristics

Water circulating system; includes water pump, fan, reservoir, heat exchangers, electronic control module, display, and keypad. Operates on standard house current. Thermal pads available in various shapes/sizes, sterile and non-sterile options. Single patient use pads.

Indications for Use

Indicated for patients requiring localized cold or heat therapy to body surfaces to lower or raise surface skin temperature.

Regulatory Classification

Identification

A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.

Special Controls

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

Predicate Devices

• Danninger Thermal-Max Thermal Therapy Unit
• InCare Hot/Ice System

Submission Summary (Full Text)

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EBI Electro Biology

Enhancing Bone Healing through Applied Science

27

K963261

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE EBI THERMAL THERAPY SYSTEM

Date Prepared: August 19, 1996

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The EBI Thermal Therapy System is intended to apply localized cold or heat therapy to body surfaces. The EBI Thermal Therapy System is designed to lower or raise the surface skin temperature by delivering water at a controlled temperature to the target site via a thermal pad. The system is designed for repeated uses in the hospital or home. The thermal pad is designed for single patient use. (Water Circulating Hot or Cold Pack Devices have been recommended by the Physical Medicine Panel for classification into Class II under 21 CFR 890.5720).

The EBI Thermal Therapy System consists of a water delivery system, insulated hoses and a thermal pad. The water delivery system includes the following components: case, water pump, fan, water reservoir, thermal exchangers, electronic control module, display, and keypad. The EBI Thermal Therapy System operates on standard house current. A variety of pads, in different shapes and sizes, are available to accommodate different anatomical sites. Both sterile and nonsterile pads are available for use with the EBI Thermal Therapy System. The EBI Thermal Therapy System is substantially equivalent to the Danninger Thermal-Max Thermal Therapy Unit and the InCare Hot/Ice System.

Comparative testing was performed on the EBI Thermal Therapy System and the Danninger Thermal-Max Thermal Therapy Unit. The performance testing demonstrates that the systems have equivalent performance characteristics.

In conclusion, the performance testing as well as the comparison of the systems' intended uses, designs and components demonstrate that the EBI Thermal Therapy System is substantially equivalent to the Danninger Thermal-Max Thermal Therapy Unit and the InCare Hot/Ice System 3.

Contact Person: Sharon A. Starowicz, Director, Regulatory Affairs
Electro-Biology, Inc.
[phone]

Electro-Biology, Inc. - A Subsidiary of Biomet, Inc. 6 Upper Pond Road, Parsippany, NJ 07054-1079 • Telephone [phone] • Toll Free 800-526-2579 • Fax [phone]