(50 days)
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.
Geen Medisox, a medical support stocking (21 CFR, 880.5780). Geen Medisox help prevent pooling of blood in the lower extremities by providing controlled graduated compression starting at 20 mmhg at the ankle and reducing to 8 mmhg at the knee. Geen Medisox are knit stockings made from cotton, Lycra, and polyamide, with gradual compression provided by the Lycra.
The provided text is a 510(k) summary for the Geen Medisox, a medical support stocking. It does not describe an AI medical device or a study with acceptance criteria and performance data as requested in the prompt. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or human-in-the-loop performance, as this information is not present in the provided document.
The document indicates that the device's substantial equivalence is based on:
- Similar materials: "Geen Medisox are knit stockings made from cotton, Lycra, and polyamide... Construction materials are similar to Jobst."
- Mode of action: "They both provide graduated compression of the lower extremities."
- Intended use: "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." and "Geen Medisox help in the treatment and prevention of varicose veins, reduce the feeling of heaviness and tiredness in legs, especially for those standing or walking all day, and also help to reduce swelling in the lower extremities."
The document explicitly states: "The product being submitted, Geen Medisox, is substantially similar to the predicate 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."
This 510(k) summary for Geen Medisox does not include any information regarding an AI algorithm, a standalone study, or a comparative effectiveness study with human readers, nor does it provide details about acceptance criteria and a study proving those criteria are met in the context of an AI device.
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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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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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
§ 880.5780 Medical support stocking.
Link to an amendment published at 90 FR 55987, Dec. 4, 2025. (a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. 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.(2)
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 system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.