SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS

K062873 · E.C.I. USA Corporation · DWL · Mar 20, 2007 · General Hospital

Device Facts

• Record ID: K062873
• Device Name: SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS
• Applicant: E.C.I. USA Corporation
• Product Code: DWL · General Hospital
• Decision Date: Mar 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.

Device Story

SunPolar Netex Medical Stockings are compression garments designed to apply controlled pressure to legs; intended to prevent blood pooling. Manufactured using circular knit machines; composed of nylon and spandex yarns. Device provides compression in 20-40mmHg range. Used by patients to manage venous circulation; functions via mechanical compression of limb tissue. No electronic components, software, or algorithms involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Medical support stocking (21 CFR 880.5780). Materials: nylon and spandex yarns. Construction: circular knit. Compression range: 20-40mmHg. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for individuals requiring controlled compression (20-40mmHg) to prevent blood pooling in the legs.

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 Travel Sock (K032325)

Submission Summary (Full Text)

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K062873

MAR 2 0 2007

## 510 (k) Summary of Safety and Effectiveness

This submission covers the SunPolar Netex Medical stockings which fall under the device classification of medical support stockings (21 CFR 880.5780). The SunPolar Netex Medical Stockings are equivalent to the Jobst Travel Sock (K032325).

Both products are produced on circular knit machines and are made of nylon and spandex yarns. They provide similar compression at the ankle. This submission covers the indication that compression stockings in the 20-40mmHg range can help to prevent the pooling of blood in the legs and apply controlled pressure to the legs.

The product being submitted is substantially equivalent to the predicate product in the materials used, mode of action, and indications for use, and can therefore be considered as safe and effective as the predicate product.

Date: January 22, 2007

Prepared by: James Wang E.C.I. (USA) Corporation 544 Fairways Circle St. Louis, MO 63141-7521 Phone: [phone]

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its head turned to the right, and its wings forming a protective shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2007

Mr. James Wang Director E.C.I (USA) Corporation 544 Fairways Circle Saint. Louis, Missouri 63141

Re: K062873

Trade/Device Name: Medical Support Stocking (Brand Name SunPolar Netex Stockings) Regulation Number: 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: January 30, 2007 Received: February 12, 2007

Dear Mr. Wang:

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.

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Page 2 - Mr. Wang

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 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

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

Enclosure

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## Indications for Use

510(k) Number (if known): 662873

Device Name: Medical Support Stocking (brand name SunPolar Netex Stockings)

Indications for Use:

Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.

Over the Counter

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Ald C. Ibyon for 3/20/07

13.23

K062873