ComfortCare Compression Support with Magnets & Anti-Bacterial Agent is designed to provide relief of minor physical discomforts that have their origin in strenuous or intense physical activities associated with athletic, workplace and at-home activities. Device provides support for relief of minor physical discomforts and at-home activities. Device provides support for relief of discomfort in self-limiting physical injuries.

ComfortCare Absortek fabric construction provides for absorption and venting of perspiration in compressed areas, minimizing potential for skin irritation.

ComfortCare Magnetic Insoles with Anti-Bacterial Agent provide foot comfort while layered absorptive fabric vents moisture from soles of feet, thereby minimizing damp environment conducive to breeding bacterial and fungal growth.

Device Description

(a) Elasticized material to support and compress a part of the body. Magnets encased in breathable fabric reader comfort. (b) Insole provides magnetic coverage of full foot insole and layered fabric absorbs and vents moisture to keep feet dry. (c) resists the growth of odor-causing bacteria and mildew

AI/ML Overview

The provided document is a 510(k) summary for a medical device modification, specifically for "ComfortCare Compression Support with Magnets & Anti-Bacterial Agent" and "ComfortCare Magnetic Insoles with Anti-Bacterial Agent." The document does not contain acceptance criteria or a study that establishes device performance against such, in the way one would expect for a performance study.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their modified device is as safe and effective as existing legally marketed devices, rather than presenting novel performance data.

Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design, ground truth establishment, sample sizes for test and training sets, MRMC studies) are not applicable or cannot be extracted from this particular type of regulatory submission. The document explicitly states: "In the absence of a classification ruling, Med Gen Inc. has referenced similar compression support products and insoles as comparative bases for substantial equivalence." and "ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices."

However, I can extract the information that is present and explain why other information is absent based on the nature of a 510(k) substantial equivalence submission.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the typical sense for a performance study. The "acceptance criteria" for a 510(k) submission of this type are based on demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially the manufacturer's assertion that the modifications (addition of magnets and anti-bacterial agents) do not alter the fundamental intended use, safety, or effectiveness compared to the predicate devices.

The document states:

"Similarities exist in 9 of 12 basic technical characteristics between ComfortCare and legally marketed products."
"The intended use, technical and safety attributes with or without magnets are essentially the same as ComfortCare products."
"ComfortCare's enhancements do not alter the intended use of 'compression support and insole products'..."
"ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices."

2. Sample size used for the test set and the data provenance

Not applicable. This document does not describe a performance study with a test set. The submission relies on a comparison of characteristics to existing legally marketed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or expert adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical device (compression support and insoles), not an AI/software device. Therefore, no MRMC study involving human readers or AI assistance would be relevant or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The ground truth for this type of submission is the established safety and effectiveness of the predicate devices to which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning or AI device that would require training data.

9. How the ground truth for the training set was established

Not applicable. This document does not describe a machine learning or AI device.

Summary

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Special 510(k): Device Modification Pre-Market Notification

DEC 0 7 2001

Section G 510(k) Summary - K013244

Submitters Name	Paul S. Mitchell, President
Corporate Name	Med Gen Inc.
Address: 7284 W. Palmetto Park Rd., Boca Raton, Florida 33433	Ph. 561-750-1100Fax 561-750-6239
Consultant	Theodore Barash561-750-1100
Date of This Summary Revision	December 5, 2001
Trade Name:	ComfortCare Compression Support withMagnets & Anti-Bacterial AgentComfortCare Magnetic Insoles with Anti-Bacterial Agent

Common Name ..................................................................................................................................................................

Class Under Section 513 ......ComfortCare Products Not Classified as of Initial Submission

Device Description - (a) Elasticized material to support and compress a part of the body. Magnets encased in breathable fabric reader comfort. (b) Insole provides magnetic coverage of full foot insole and layered fabric absorbs and vents moisture to keep feet dry. (c) resists the growth of odor-causing bacteria and mildew

Intended Use - (a) The compression support line with magnets is designed for the relief of minor discomfort that may have resulted from a simple accident, energetic sports-related or intense workplace activities. Absorption and venting of perspiration keeps targeted anatomical area dry minimizing potential for skin irritation. (b) Magnetic insoles provide comfort, with layered absorptive fabric venting moisture from soles of feet, thereby minimizing damp environment conducive to breeding bacterial and fungal growth.

Technological Character - Among the leading brands, similarities cxist in 9 of 12 basic technical characteristics between ComfortCare and legally marketed products, General suppression support marketers (ie Becton-Dickinson and Ace) differ only to the extent that they use neoprene compression and wrap-around clastic fabrica respectively, without the use of magnets or anti-microbials. Among dominant marketers with magnets such as Homedics and Nikken, differences exist in their use of neoprene for compression support without fabric absorption properties and without anti-microbial agents as compared to Without Care, In all cases, however, the intended use, technical and safety attributes with or without magnets are essentially the same as ComfortCare products.

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510(k) Summary (continued) K013244 Section G

Summary - In the absence of a classification ruling, Med Gen Inc. has referenced similar compression support products and insoles as comparative bases for substantial equivalence.

1. Such type products are in broad common use in the USA and throughout the world.
1. ComfortCare's enhancements do not alter the intended use of 'compression support and insole products' as identified in Section 880.6075 and Section 880.6280 respectively.
1. ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices.
1. ComfortCare's packaging makes no structure/function claims, provides no specific indications and minimally uses magnetic references.
1. The copy emphasis on each product's packaging of ComfortCare is on 'compression I he copy chipface on care care's fitments and 'perspiration control' for its insole, with anti-microbial agent.
1. The standard that any proposed device be substantially equivalent relies on the premise that any change does not effect or alter the fundamental science and safety of legally marketed devices, the risk posed by the medical device and reasonable equivalency in technological characteristics and, not necessarily identical.
1. Given the above, Med Gen Inc. respectfully submits that this application qualifies for classification of its products into Section 880.5075 for Elastic Bandages and Section 880.628() for medical insoles.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three wavy lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 7 2001

Mr. Thedore Barash Consultant Med Gen, Incorporated 7284 W. Palmetto Park Road Boca Raton, Florida 33433-3406

Re: K013244

Trade/Device Name: ComfortCare Compression Support with Magnets and Anti-Bacterial Agent; ComfortCare Magnets Insoles and Anti-Bacterial Agent Regulation Number: 880.5075 and 880.6280 Regulation Name: Elastic Bandage and Medical Insole Regulatory Class: I Product Code: FQM and KYS Dated: September 24, 2001 Received: September 28, 2001

Dear Mr. Barash:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other

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Page 2 - Mr. Barash

requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

Timothy A. Ulatowski 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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Page 1 of 1

510(k) Number K013244

Trade Name: ComfortCare Compression Support with Magnets & Anti-Bacterial Agent.

Agent. ComfortCare Compretic Insole with Anti-Bacterial Agent

Revision of December 5, 2001

Indications for Use:

ComfortCare Compression Support with Magnets & Anti-Becterial Agent is designed to provide ComfortCare Compression Support with Magness or intributions of register actions
relief of minor physical discomforts that have their origin in strenger for relief of minor physical discollubris and at-home actives. Device provides support for associated with athletic, workplace and at-nome activities: Doviet of creation in self-limiting physical injuries.

ComfortCare Absortek fabric construction provides for absorption and venting of perspiration in Comforceded areas, minimizing potential for skin irritation.

ComfortCare Magnetic Insoles with Anti-Bacterial Agent provide foot comfort while layered ComfortCare Magnetic Insoles with Anti-Dacterial Right provironment conducive to breeding bacterial and fungal growth.

Patricia Cucuriti

vision Sign-Off Division of Dental, Infection Control, and General Hospital Devices K013244 510(k) Number.

Regulation Number and Section

§ 880.5075 Elastic bandage.

Link to an amendment published at 90 FR 55986, Dec. 4, 2025. (a)
Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.(b)
Classification. Class I (general 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. The device also is 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.