PBS MODEL 701A COMPRESSION THERAPY DEVICE

K060220 · Mego Afek · JOW · Feb 9, 2006 · Cardiovascular

Device Facts

• Record ID: K060220
• Device Name: PBS MODEL 701A COMPRESSION THERAPY DEVICE
• Applicant: Mego Afek
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treatment of Venous disorders and Dysfunction of the "Muscle Pump"

Device Story

PBS (Petit Basic System) Model 701A is a compression therapy device. It applies external pressure to limbs to treat venous disorders and muscle pump dysfunction. The device consists of a controller and a compressible limb sleeve. It is intended for prescription use. By providing intermittent or sequential compression, it assists in venous return and blood circulation, potentially reducing edema and improving symptoms associated with venous insufficiency.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Compressible limb sleeve system (21 CFR 870.5800, Product Code JOW). Operates as a pneumatic compression device. Class II medical device.

Indications for Use

Indicated for the treatment of venous disorders and dysfunction of the muscle pump in patients requiring compression therapy.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Submission Summary (Full Text)

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## SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS

Kobo2ZO

(Premarket Notification [510(k)] Number)

## 1. Applicant

Mego Afek Ltd. Kibbutz Afek Post Afek ISRAEL 30042 Tel: [phone] Fax: [phone]

Corresponding Official:

Name: Ahava M. Stein, Consultant Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Tel: [phone] Fax: [phone]

| 2. Device Name: | PBS Compression Therapy Device |
|--------------------------------|--------------------------------------------------------------------|
| Device trade/proprietary name: | PBS (Petit Basic System) Model 701 A<br>Compression Therapy Device |
| Common Name: | Compression Therapy Device |
| Classification Name: | Compressible Limb Sleeve (product code JOW,<br>Class II, 870.5800 |

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 9

Mego Afek c/o Mr. Ahava M. Stein Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as Street 44425 Kfar Saba ISRAEL

Re: K060220

PBS Model 701A Compression Therapy Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: January 18, 2006 Received: January 30, 2006

Dear Mr. Stein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becased on and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the energly, 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). and Cosmetier for , 10 / ket 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. Ahava M. Stein

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 Bart 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), 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/cdrl/industry/support/index.html.

Sincerely yours,

Duna R. Lochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

Page 1 of 1

510(k) Number (if known): _____ ڪ ڪ 26 PBS (Petit Basic System) Compression Therapy device Device Name: Indications for use: Treatment of Venous disorders and Dysfunction of the "Muscle Pump"

Prescription Use _ V (Per 21 C.F.R. 801.109)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Donna R. Viihnes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ko6220__________________________________________________________________________________________________________________________________________________________