Phlebo Press DVT 603

K142772 · Mego Afek AC , Ltd. · JOW · Dec 16, 2014 · Cardiovascular

Device Facts

• Record ID: K142772
• Device Name: Phlebo Press DVT 603
• Applicant: Mego Afek AC , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Dec 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phlebo Press DVT 603 is intended for use by medical professionals and patients who are under medical supervision, in treating conditions such as: - Prevention of deep vein thrombosis (DVT) in patients who may be susceptible - Reduction of pain and swelling after injury and surgery - Enhancement of venous circulation - Prevention of venous stasis - Assistance in healing of cutaneous ulcers - Reduction of compartmental pressures The device is intended for hospital, home and clinic use

Device Story

Phlebo Press DVT 603 is a compressible limb sleeve system; provides intermittent pneumatic compression to limbs. Used in hospital, clinic, or home settings; operated by medical professionals or patients under supervision. Device applies external pressure to enhance venous circulation, prevent venous stasis, and reduce compartmental pressures; aids in DVT prevention and post-surgical/injury swelling reduction. System consists of a controller unit and inflatable sleeves; functions via pneumatic inflation cycles. Output is mechanical compression; assists clinical management of vascular and post-operative conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison to predicate devices.

Technological Characteristics

Compressible limb sleeve system; pneumatic inflation mechanism; controller unit with inflatable sleeves. Intended for hospital, home, and clinic use. Class II device under 21 CFR 870.5800.

Indications for Use

Indicated for patients susceptible to DVT, patients requiring reduction of pain/swelling post-injury/surgery, enhancement of venous circulation, prevention of venous stasis, assistance in healing cutaneous ulcers, and reduction of compartmental pressures. For use by medical professionals or patients under medical supervision.

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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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2015

Mego Afek AC Ltd Aharon Cohen QA & RA Manager Kibbutz Afek Afek, 30042, Israel

Re: K142772

Trade/Device Name: Phlebo Press DVT 603 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Dated: September 30, 2014 Received: October 3, 2014

Dear Aharon Cohen:

This letter corrects our substantially equivalent letter of December 16, 2014.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely vours.

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

510(k) Number (if known)

Device Name Phlebo Press DVT 603

Indications for Use (Describe)

The Phlebo Press DVT 603 is intended for use by medical professionals and patients who are under medical supervision, in treating

conditions such as:

- * Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
- * Reduction of pain and swelling after injury and surgery
- * Enhancement of venous circulation
- * Prevention of venous stasis
- * Assistance in healing of cutaneous ulcers
- * Reduction of compartmental pressures

The device is intended for hospital, home and clinic use

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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