← Product Code [JOW](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW) · K963067 # SOF. PRESS EPC 51 SYSTEM (K963067) _Gaymar Industries, Inc. · JOW · Jan 28, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K963067 ## Device Facts - **Applicant:** Gaymar Industries, Inc. - **Product Code:** [JOW](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW.md) - **Decision Date:** Jan 28, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.5800 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 (716) 662-2551 / (800) 828-7341 FAX #: (716) 662-6120 {1} # 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 | --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K963067](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K963067) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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