(15 days)
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 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.
This document is a 510(k) premarket notification decision letter for a medical device, the MedMark Technologies, LLC Model GS-128 Sequential Compression System. It confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.
The document provided does not contain information regarding acceptance criteria, device performance results, or details of any studies conducted. It is a regulatory clearance letter, not a study report. Therefore, I cannot extract the requested information points from this input.
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Public Health Service
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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 (301) 594-4646. Additionally, for questions on the contact the Office of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (201) 594-4097. 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 (800) 638-2041 or (301) 443-6597 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
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
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
§ 870.5800 Compressible limb sleeve.
(a)
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.(b)
Classification. Class II (performance standards).