The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The WizAir DVT™ is intended for use in: Preventing Deep Vein Thrombosis (DVT). Enhancing blood circulation. Diminishing post-operative pain and swelling. Reducing wound-healing time. Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers. Treatment of chronic venous insufficiency. Reducing edema.

Device Description

The WizAir DVT™ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the WizAir DVT™ is light and compact, thus making it a portable ambulant system. The WizAir DVTTM provides the user with an option of battery operation in addition to the operation from the mains option. The WizAir DVT™ is easy to use and provides the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two cuffs. The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a a sequential intermittent gradient application of a pressure to a three-celled calf cuff.

AI/ML Overview

This document describes a 510(k) submission for the WizAir DVT™, a pneumatic compression device. The provided text, however, does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on:

Device Description: What the WizAir DVT™ is and how it works.
Indications for Use: The medical conditions the device is intended to prevent or treat.
Contraindications: Situations where the device should not be used.
Regulatory Information: Classification, product code, applicant details, and the FDA's decision regarding substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory clearance letter, not a clinical study report or a detailed performance validation document.

Summary

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012994 2/2

MAR 2 7 2002

510(K) SUMMARY

WizAir DVT™

510(k) Number K

Applicant's Name:

Medical Compression Systems (DBN) Ltd. 13 Granit Street, Building No. 32 P.O. Box 7515 Caesarea Industrial Park (North) 38900, Israel Tel: +972 (4) 6379895 Fax: +972 (4) 6379152

Contact Person:

Shoshana Friedman, RAC Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131

Trade Name:

WizAir DVT™

Classification Name:

Compressible Limb Sleeve

Classification:

Class II; Product Code JOW; Regulation No. 870.5800.

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Device Description:

The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a a sequential intermittent gradient application of a pressure to a three-celled calf cuff.

Indications:

The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.

The WizAir DVT™ is intended for use in:

Preventing Deep Vein Thrombosis (DVT). .
Enhancing blood circulation. .
Diminishing post-operative pain and swelling. ●
Reducing wound-healing time. .
Treatment and assistance in healing: stasis ● dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers.
Treatment of chronic venous insufficiency. .
Reducing edema.

Contraindications:

The WizAir™ system should not be used in the following cases: fresh pre-existing DVT, pulmonary embolism, leg gangrene, recent skin graft, acute thrombophlebitis and in medical situations where increased venous and lymphatic return is undesirable

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2002

Medical Compression Systems (D.B.N.) Ltd. c/o Mr. Shoshana Friedman, RAC Managing Director Push-med Ltd. 117 Ahuzah Street Ra'ananna 43373 ISRAEL

Re: K012994 Trade Name: WizAir DVTTM Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: December 24, 2001 Received: December 27, 2001

Dear Mr. Friedman:

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. Shoshana Friedman, RAC

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 or uny I odotal statuates and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of A rat 80 7) Moores (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 promated notification. The 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) 594-4646. 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,

Elias Mallis

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

WizAir DVTIM Device Name:

Indications for Use:

The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.

The WizAir DVT™ is intended for use in:

Preventing Deep Vein Thrombosis (DVT). .
Enhancing blood circulation. .
Diminishing post-operative pain and swelling. .
Reducing wound-healing time. .
Treatment and assistance in healing: stasis . dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers.
Treatment of chronic venous insufficiency. ●
Reducing edema. .

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

Division of Cardiovascular & Respiratory Devices 510(k) Number

Em OVio

510(k) Number Koi 2994

Prescription Use _ X (Per 21 CFR 801.109) OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
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.(b)
Classification. Class II (performance standards).