COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES

K013239 · Med Gen, Inc. · FMQ · Nov 20, 2001 · General Hospital

Device Facts

• Record ID: K013239
• Device Name: COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
• Applicant: Med Gen, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

ComfortCare Compression Support with Magnets is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive activities associated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable areas of the body to assist in the prevention of athletic injuries. ComfortCare Absortek fabric construction provides for absorption and venting of perspiration, minimizing potential for skin irritation. ComfortCare Magnetic Insoles provide foot comfort while layered absorptive fabric vents moisture to keep feet dry, thereby minimizing damp layers that could promote bacterial and fungal growth.

Device Story

ComfortCare products consist of elasticized compression supports and medical insoles embedded with static magnets. Supports are worn on body areas to provide compression and support during athletic or workplace activities; insoles are placed in footwear. The device uses Absortek fabric to absorb and vent perspiration, aiming to reduce skin irritation and prevent bacterial/fungal growth. Magnets are included for therapeutic effect, though the manufacturer emphasizes compression and moisture control in labeling. The device is intended for non-invasive, drug-free relief of minor discomforts. It is used by consumers in home, workplace, or athletic settings. The healthcare provider or user evaluates the device based on its ability to provide physical support and comfort.

Clinical Evidence

No clinical data. The submission relies on the historical use of magnets, general safety limits (20,000 Gauss), and the established safety/efficacy of the underlying compression and insole technologies. The manufacturer cites the potential for a placebo effect as a non-invasive, drug-free option for minor, self-limiting symptoms.

Technological Characteristics

Elasticized fabric compression supports and medical insoles. Features Absortek fabric for moisture management. Incorporates static magnets. No specific ASTM standards cited. Standalone, non-powered, non-electronic device.

Indications for Use

Indicated for individuals experiencing minor physical discomforts resulting from stress and strain of repetitive athletic, workplace, or at-home activities. Provides support for vulnerable body areas to assist in injury prevention and foot comfort through moisture management.

Regulatory Classification

Identification

A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

Reference Devices

• Becton Dickinson compression supports
• Ace compression supports

Submission Summary (Full Text)

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K013239

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

## Section G 510(k) Summary

NOV 2 0 2001

| Submitters Name | Paul S. Mitchell, President |
|---------------------------------------------------------------|------------------------------------------------------------------------------|
| Corporate Name | Med Gen Inc. |
| Address: 7284 W. Palmetto Park Rd., Boca Raton, Florida 33433 | Ph. 561-750-1100<br>Fax [phone] |
| Consulant | Theodore Barash<br>561-750-1100 |
| Date of This Summary Preparation | September 21, 2001 |
| Trade Name: | ComfortCare Compression Support with Magnets<br>ComfortCare Magnetic Insoles |
| Common Name | Elastic Bandage and Medical Insole |
| Class Under Section 513 | ComfortCare Products Not Classified |

Device Description - (a) Elasticized material to support and compress a part of the body. Device Description – (a) Elasticized inaterial to support. (b) Insole provides magnetic Magnets encased in breadlable labric reader comers (a) (ents moisture to keep feet dry.

Intended Use – (a) The compression support line with magnets is designed for the relief of Intended Use = (a) The compression supportune simple accident, encreatic sports-related or
minor discomfort that may have resulted from a simple accident targeted intense workplace activities. Absorption and venting of perspiration keeps targeted intense workplace actrines: "Fiborphile for skin irritation. (b) Magnetic insoles with analomical area ury minimizing posture from soles of feet, thereby minimizing damp layer co absol prive inwe to breeding bacterial and fungal growth.

Technological Character -- Among the leading brands, similarities exist in 9 of 1 1 basic I echnical characteristics between ComfortCare and legally marketed products. General technical characteristics between Obickinson and Ace) differ only to the extent that Suppression support mail keters (10 Decam 200und elastic fabrics respectively, without the they use neoplene compression and weap are . Among dominant marketers with magnets use of magicus. Fuller of dood not afferences exist in their use of neoprene for compression. Such as Homeones and Pinsters, in properties as compared to ComfortCare. In all cases, Support without fabric absorphous profibutes and safety of products in this classification, with or without magnets, are essentially the same as ComfortCare products.

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

## Section G 510(k) Summary (continued)

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.
- 2) ComfortCare's enhancements do not alter the intended use of 'compression support and insole products' as identified in Section 880.5075 and Section 880.6280 respectively.
- 3) The addition of static magnets at present levels of commercial use, do not present any history of adverse effects as reported by the World Health Organization. Numerous studies, support the safety limits of 20,000 Gauss which have been determined not to produce any detrimental effect on health.
- 4) Magnets have been in use for thousands of years and provide testimony to some level of therapeutic effect that impel its continued life span, placebo effect not withstanding.
- 5) Although the existence of placebo effect has been challenged recently, other studies suggest that placebo effect may be a factor in the same physical response induced by ethical drugs for certain conditions. Some reports indicate that placebo may well represent up to 35% of the desired effect in the administration of certain approved ethical drugs. If magnets work at some placebo level, magnets may be a non-invasive drug-free option for minor discomfort, particularly for 9 of 10 symptoms of the selflimiting variety.
- 6) ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices.
- 7) ComfortCare's packaging makes no structure/function claims, provides no specific indications and minimally uses magnetic references.
- 8) The copy emphasis on each product's packaging of ComfortCare is on 'compression and support' for ComfortCare's fitments and 'perspiration control' for its insole. Magnets have been de-emphasized.
- 9) 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.
- 10) 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 880.6280 for medical insoles.

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Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an abstract symbol. The symbol appears to be a stylized representation of a human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

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

Re: K013239

Trade/Device Name: ComfortCare Compression Support with Magnets ComfortCare Magnetic Insole Regulation Number: 880.5075 and 880.6280 Regulation Name: Elastic Bandage and Medical Insole Regulatory Class: I Product Code: FMQ and KYS Dated: September 25, 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 requirements

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Page 2 -- Mr. Barash

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 [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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/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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K 013257

NOV 2 0 2001

Page 1 of 1

## 510(k) Number K013239

Device Name: ComfortCare Compression Support with Magnets. ComfortCare Magnetic Insole

## Revision of October 30, 2001

Indications for Use:

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(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 0323 110(k) Number __