SOF. PRESS EPC 51 SYSTEM

K963067 · Gaymar Industries, Inc. · JOW · Jan 28, 1997 · Cardiovascular

Device Facts

• Record ID: K963067
• Device Name: SOF. PRESS EPC 51 SYSTEM
• Applicant: Gaymar Industries, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jan 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To aid in the reduction and management of peripheral edema such as lymphedema and ulceration associated with vascular insufficiency.

Device Story

External pneumatic compression system; consists of pump, inflatable three-cell sleeve, and connection tubing. Operates by sequential inflation of sleeve cells; highest pressure applied distally, decreasing pressure proximally. Used in clinical or home settings to manage peripheral edema. Healthcare provider or patient uses device to apply intermittent compression to limbs; aids in fluid reduction and vascular management. Includes pressure relief valve for safety.

Clinical Evidence

Bench testing only. Biocompatibility testing performed including primary skin irritation, delayed contact sensitization, and cytotoxicity. Electrical safety verified via UL 544 compliance.

Technological Characteristics

Pneumatic sequential pump; three-cell inflatable sleeve; connection tubing. Pressure relief valve included. Electrical safety: UL 544. Biocompatibility: passed primary skin irritation, delayed contact sensitization, and cytotoxicity testing.

Indications for Use

Indicated for patients requiring reduction and management of peripheral edema, including lymphedema and ulceration associated with vascular insufficiency.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• Jobst Extremity Pump System 7500
• Huntleigh Flowpress AC300

Submission Summary (Full Text)

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JAN 28 1997
K963067

# GAYMAR®

GAYMAR INDUSTRIES, INC.

## Premarket Notification [510(K)] Summary

| Submitter: | Peter Scott |
| --- | --- |
| Phone: | 716/662-2551, ext. 676 |
| FAX: | 716/662-8763 |
| Date Summary Prepared: | July 26, 1996 |
| Device Name: | Sof.Press EPC 51 System |
| Common Name: | Pneumatic Sequential Pump |
| Classification Name: | Compressible Limb Sleeve per 21 CFR, Section 870.5800 |
| Predicate Device: | Jobst Extremity Pump System 7500 and
Huntleigh Flowpress AC300 |

## Intended Use of Device:

To aid in the reduction and management of peripheral edema such as lymphedema and ulceration associated with vascular insufficiency.

## Description:

The Sof.Press EPC 51 System is an external pneumatic compression device that consists of a pump, an inflatable three cell sleeve, and connection tubing. Each cell of the sleeve is inflated sequentially with the highest pressure applied distally and with successively lesser pressures applied proximally.

## Substantial Equivalence:

The following tables, Sof.Press Product Comparison Chart and the Safety Summary Chart, summarize the technological characteristics and the nonclinical performance data upon which the substantial equivalence submission was made to the Food and Drug Administration.

10 CENTRE DRIVE
ORCHARD PARK, NY 14127
[phone] / [phone]
FAX #: [phone]

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# SAFETY SUMMARY CHART

| | Sof.Press | Jobst 7500 | HNE 300 |
| --- | --- | --- | --- |
| Biocompatibility | | | |
| Primary skin irritation | pass | unknown | unknown |
| Delayed contact sensitization | pass | unknown | unknown |
| Cytotoxicity | pass | unknown | unknown |
| Flammability | pass | unknown | unknown |
| UL Approvals | UL 544 | personal health care appliance
UL 1431 | UL 544 |
| Pressure Relief Valve | yes | yes | no |