GEEN MEDISOX

K981296 · Geen Healthcare, Inc. · DWL · May 29, 1998 · General Hospital

Device Facts

• Record ID: K981296
• Device Name: GEEN MEDISOX
• Applicant: Geen Healthcare, Inc.
• Product Code: DWL · General Hospital
• Decision Date: May 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GEEN MEDI SOX GRADUATED COMPRESSI ON SOCKS HAVE BEEN DESIGNED TO PREVENT POOLING OF BLOOD I N THE LOWER EXTREMI TI ES BY APPLYI NG CONTROLLED GRADUATED COMPRESSION STARTING AT 20 MMHG AT THE ANKLE AND REDUCING TO 8 MMHG AT THE KNEE. GEEN MEDISOX HELP IN THE TREATMENT AND PREVENTI ON OF VARI COSE VEINS, REDUCE THE FEELING OF HEAVINESS AND TIREDNESS IN LEGS, ESPECIALLY FOR THOSE STANDING OR WALKING ALL DAY, AND ALSO HELP TO REDUCE SWELLI NG IN THE LOWER EXTREMITIES.

Device Story

Geen Medisox are knit stockings designed to prevent blood pooling in lower extremities. Device applies controlled graduated compression, starting at 20 mmHg at ankle and reducing to 8 mmHg at knee. Compression is provided by Lycra content within knit fabric. Intended for use by individuals suffering from leg heaviness, tiredness, or swelling, including those with occupations requiring prolonged standing or walking. Device functions as a passive mechanical support; no external power or electronic processing required. Patient self-applies stockings to legs to provide therapeutic pressure, aiding venous return and symptom relief.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and mode of action similarity to predicate devices.

Technological Characteristics

Knit stockings composed of cotton, Lycra, and polyamide. Graduated compression (20 mmHg at ankle to 8 mmHg at knee) achieved via mechanical properties of Lycra. Passive device; no energy source, software, or connectivity.

Indications for Use

Indicated for individuals experiencing heaviness or tiredness in legs, particularly those standing or walking for extended periods, and for the treatment and prevention of varicose veins and lower extremity swelling.

Regulatory Classification

Identification

Medical support stocking to prevent the pooling of blood in the legs: A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg. Medical support stocking for general medical purposes: A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.

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 the limitations in § 880.9.(b) *Medical support stocking for general medical purposes* —(1)*Identification.* A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2) *Classification.* Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Predicate Devices

• Jobst stockings

Submission Summary (Full Text)

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K 981296

Image /page/0/Picture/1 description: The image shows the logo for GEEN Healthcare INC. The word "GEEN" is in large, bold, black letters. Below it, "HEALTHCARE" is written in smaller, black letters, and below that, "INC" is written in even smaller letters.

931 PROGRESS AVENUE · UNIT 13 ROUGH · ONTARIO OLL FREE 800 565 GEEN

MAY 2 9 1998

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

a medical support This submission covers Geen Medisox, stocking (21 CFR, 880.5780).

Geen Medisox help prevent pooling of blood in the lower Geen Nedison help pring controlled graduated compression excreating at 20 mmhg at the ankle and reducing to 8 mmhg at the knee.

Geen Medisox are substantially equivalent to preamendment
Jobst stockings (510K numbers listed in Section D of the Premarket Submission Cover Sheet) as they use similar materials, mode of action, and are intended for the same use.

Geen Medisox are knit stockings made from cotton, Lycra, and polyamide, with gradual compression provided by the Lycra. Construction materials are similar to Jobst, and the mode of action for both products is the same. They both provide graduated compression of the lower extremities.

The product being submitted, Geen Medisox, is substantially ine product being bability product in the materials used, mode of action, and indications for use. It has a long history of use and has proven to be as safe and effective as the predicate product.

DATE: March 23, 1998

PREPARED BY: Greg W. Geen Geen Healthcare Inc. Scarborough, ON MIG 3V5 Canada

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that suggest movement or flow.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 1998

Mr. Greg W. Geen · President Geen Healthcare, Incorporated 931 Progress Avenue, Unit 13 Scarborough, Ontario CANADA MIG 3V5

Re : K981296 Trade Name: Geen Medisox Regulatory Class: II Product Code: DWL Dated: April 7, 1998 Received: April 9, 1998

Dear Mr. Geen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Geen

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K981296

## 21 of Page 21

510(k) NUMBER (IF KNOWN) : K981296 DEVICE NAME: GEEN MEDISOX GRADUATED COMPRESSION SOCKS INDICATIONS FOR USE:

> GEEN MEDI SOX GRADUATED COMPRESSI ON SOCKS HAVE BEEN DESIGNED TO PREVENT POOLING OF BLOOD I N THE LOWER EXTREMI TI ES BY APPLYI NG CONTROLLED GRADUATED COMPRESSION STARTING AT 20 MMHG AT THE ANKLE AND REDUCING TO 8 MMHG AT THE KNEE.

GEEN MEDISOX HELP IN THE TREATMENT AND PREVENTI ON OF VARI COSE VEINS, REDUCE THE FEELING OF HEAVINESS AND TIREDNESS IN LEGS, ESPECIALLY FOR THOSE STANDING OR WALKING ALL DAY, AND ALSO HELP TO REDUCE SWELLI NG IN THE LOWER EXTREMITIES.

DATE: April 30, 1998 PREPARED BY: Greq W. Geen Geen Healthcare Inc. Scarborough, ON Canada M1G 3V5

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

Patricia Cucciollo
(Division Sign-Off)

Division of Donel, Infected. and General Hospital Devices

510(k) Number K981296