AVIAFIT PULSATING LEGBAND

• K Number: K071744
• Device Name: AVIAFIT PULSATING LEGBAND
• Manufacturer: FLOWMEDIC LTD.
• Date Cleared: 2007-09-25 ( 90 days)
• Product Code: JOW
• Regulation Number: 870.5800
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: K111720

Intended Use

The Aviafit™ is intended to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions at home, at the office and during mid-long haul flights.

Device Description

AviaFit™ Pulsating Legband

AI/ML Overview

This document is a 510(k) summary for the AviaFit™ Pulsating Legband. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth.

Therefore, the requested information cannot be extracted from the provided text. The document confirms the FDA has found the device substantially equivalent to a legally marketed predicate device, but it lacks the specific study details needed to answer the questions about acceptance criteria and performance data.

Summary

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SECTION 5 - 510(K) SUMMARY

AVIAFIT™ DEVICE 510(k) Number K_◎フ/フ 44

SEP 25 2007

Applicant's Name:

Company name: FlowMedic Ltd.
Address:	15 Alon Hatavor St.
	Industrial Area Caesarea
	Caesarea, 38900
	ISRAEL
Tel.:	[phone]
Fax:	[phone]
E-mail:	[e-mail]

Contact Person:

Contact Name:	Ahava Stein
Company:	A. Stein - Regulatory Affairs Consulting
Address:	20 Hata'as St. (P.O.B. 124)Kfar Saba 44425ISRAEL
Tel.:	[phone]
Fax:	[phone]
E-mail:	[e-mail]

Date Prepared:

Date: June 20, 2007

Name of the device:

AviaFit™ Pulsating Legband

Trade or proprietary name, if applicable:

AviaFit™ Pulsating Legband

Common or usual name:

Compressible Limb Sleeve

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing health, human services, and well-being. 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

SEP 2 5 2007

FlowMedic Ltd. c/o Ms. Ahava Stein Regulatory Affairs Consulting Ltd. Beit Hapaamon Suite 102 20 HATAAS Str. (P.O.B 124) Kfar Saba 44425 Israel

Re: K071744 AviaFit™ Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: September 2, 2007 Received: September 7, 2007

Dear Ms. Stein:

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 - Ms. Ahava 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrh/industry/support/index.html.

Sincerely yours,

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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SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	Ko71744
	Comments of the comments on an experience and proportions and consideration and consideration of the comments of

Device Name:

AviaFit™ Device

Indications for use:

The Aviafit™ is intended to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions at home, at the office and during mid-long haul flights.

Prescription Use (Per 21 C.F.R. 801 Subpart D)

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OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

сестор

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K071744

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5

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).