GS-128 GRADIENT COMPRESSION SYSTEM

K050584 · Medmark Technologies, LLC · JOW · Mar 22, 2005 · Cardiovascular

Device Facts

• Record ID: K050584
• Device Name: GS-128 GRADIENT COMPRESSION SYSTEM
• Applicant: Medmark Technologies, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Mar 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The GS-128 Gradient Compression System is a sequential gradient compression pneumatic device used for the treatment and management of venous or lymphatic disorder of the limbs.

Device Story

GS-128 is a sequential gradient compression pneumatic device; provides therapy for venous or lymphatic limb disorders. Used in home, physical therapy clinics, physician offices, and hospital recovery/PT environments. Operates by applying sequential pneumatic pressure to limbs to manage edema and venous conditions. Healthcare providers prescribe the device for patient use; patients or clinicians operate the system. Output is mechanical compression; benefits include reduction of edema and management of venous/lymphatic insufficiency.

Clinical Evidence

No clinical data provided; device cleared based on substantial equivalence to existing pneumatic compression systems.

Technological Characteristics

Sequential gradient compression pneumatic device. Class II, Product Code JOW. Operates via pneumatic pressure delivery to limb sleeves. Intended for prescription and over-the-counter use.

Indications for Use

Indicated for patients with peripheral edema, lymphedema (postmastectomy, congenital), venous stasis ulcers, venous insufficiency, stump reduction, and hand edema.

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.

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol is composed of three curved lines that converge at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2005

MedMark Technologies, LLC. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Mecting, PA 19462-1298

Re: K050584 Model GS-128 Sequential Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: March 7, 2005 Received: March 7, 2005

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave te review your we determined the device is substantially equivalent (for the indications forcreneve above and harsure) to legally marketed predicate devices marketed in interstate for use surved in the encrease 1976, the enactment date of the Medical Device Amendments, or to conninered pror to rial 2011-11-11, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetter fore, market the device, subject to the general controls provisions of the Act. The r va may, mereleve, mixins of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to sater adderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Robert Mosenkis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issumter of a succession of the requirements of the Act that FDA has made a determination administered by other Federal agencies. You must of any Federal Statutes and regulations daminding, but not limited to: registration and listing (21 comply with an the Act 31equirements, and manufacturing practice requirements as set CFK Fart 807), adoling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2) ===================================================================================================================================== This letter will anow you to oegin mailing of substantial equivalence of your device to a legally premarket nothleation: "The PDF Interingssification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at [phone]. Additionally, for questions on the contact the Office of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to [phone]. Alloo, predo not more of 97) you may obtain. Other general information on your promatics nontroution - (Act may be obtained from the Division of Small Manufacturers, ItSponsionnies and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Divya R. Richter1

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known):

Device Name: Medmark Technologies, LLC, Compression Pump, Model GS-128

K050584

Intended Use:

The GS-128 Gradient Compression System is a sequential gradient compression pneumatic device used for the treatment and management of venous or lymphatic disorder of the limbs.

Indications For Use:

Common Indications Peripheral edema Lymphedema (Postmastectomy, congenital) Venous Stasis Ulcers Venous Insufficiency Stump reduction Hand edema

The Intended Clinical Settings are as follows:

- In-Home Patient Therapy r
- Physical Therapy Clinics/Physician's Office t
- Hospital Patient Recovery Room Environments 风
- Hospital Physical Therapy Environments I

The Intended Patient Population are patients who are diagnosed with the above listed indications.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Education (ODE)

(Posted November 13, 2003)

DURRE P. WICKENS

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number k050584

PAGE 1/2 * RCVD AT 2/22/2005 3:52:21 PM [Eastern Standard Time] * SVR:ECRFAX/2 * DN/S:1175 * CSD:2152491029 * DURATION (mm-s):00-52