THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM

K961621 · Therapy Concepts, Inc. · ILO · Oct 31, 1996 · Physical Medicine

Device Facts

• Record ID: K961621
• Device Name: THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM
• Applicant: Therapy Concepts, Inc.
• Product Code: ILO · Physical Medicine
• Decision Date: Oct 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Therapy Concepts Water Circulating Treatment System will be used to pump chilled or room temperature water through a plastic pad that is placed on a mattress underneath the user and in so doing, will provide cold temperature therapy intended to temporarily assist in the localized reduction of minor swelling and pain. Pre-chilled water will be provided by adding ice cubes and water to the reservoir. The cooling rate is adjusted by adjusting the rate of flow of the water through the plastic pad.

Device Story

Water circulating treatment system; consists of 1.5L water reservoir, low voltage DC pump, wall-mounted 7.5V DC power supply, plastic/foam pad with internal channels, and nylon carrying case. User adds ice and water to reservoir; pump circulates fluid through pad placed on mattress under user. Cooling rate controlled by adjusting water flow rate. Used for localized reduction of minor swelling and pain.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System components: 1.5L reservoir, DC pump, 7.5V DC power supply, plastic/foam pad with internal circulation channels. Energy source: 7.5V DC. Form factor: modular system with carrying case.

Indications for Use

Indicated for patients requiring cold temperature therapy for the temporary localized reduction of minor swelling and pain.

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

• HOT/ICE Cold Therapy Cooler System (catalog number 42000)

Submission Summary (Full Text)

{0}

From: Jim Taylor To: FDA - Attn: Tracy Bourke Date: 10/29/96 Time: 16:41:23 Page 2 of 2

# OCT 31 1996

## Section 10 - Summary of Safety and Effectiveness K961621

| Date of Preparation: | October 29, 1996 |
| --- | --- |
| Device Name: | Therapy Concepts Water Circulating Treatment System |
| Classification Name: | Pack, Hot or Cold Water, Circulating - 89 ILO |
| Manufacturer: | Therapy Concepts, Inc. located at 11445 Moog Drive, St. Louis, MO 63146 (314) |
| Predicate Device: | HOT/ICE Cold Therapy Cooler System, catalog number 42000, manufactured and marketed by InCare Medical Products, a division of Hollister Inc., 2000 Hollister Drive, Libertyville, IL 60048. |
| Device Description: | The Therapy Concepts Water Circulating Treatment System will consist of five discreet modules. A reservoir module holding 1.5 liters of water. A low voltage DC pump with integral connection tubing. A wall mounted power supply to provide 7.5 volts DC to power the pump. A plastic/foam pad with connecting tubing, containing channels through which water is circulated and a form fitted sewn nylon carrying case. |
| Intended Use: | The Therapy Concepts Water Circulating Treatment System will be used to pump chilled or room temperature water through a plastic pad that is placed on a mattress underneath the user and in so doing, will provide cold temperature therapy intended to temporarily assist in the localized reduction of minor swelling and pain. Pre-chilled water will be provided by adding ice cubes and water to the reservoir. The cooling rate is adjusted by adjusting the rate of flow of the water through the plastic pad. |
| Clinical and Non-Clinical Similarities and Differences: | The Therapy Concepts, Inc. Water Circulating Treatment System and the InCare Medical Products, Inc. HOT/ICE Cold Therapy Cooler System are substantially equivalent since they both provide cold temperature therapy to temporarily assist in the localized reduction of minor swelling and pain. |

23