Phlebo Press DVT Model

K172277 · Mego Afek AC , Ltd. · JOW · Nov 3, 2017 · Cardiovascular

Device Facts

• Record ID: K172277
• Device Name: Phlebo Press DVT Model
• Applicant: Mego Afek AC , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Nov 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phlebo Press DVT Model 760D including compression garments is intended for use by healthcare 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 - · Reducing edema - · Treatment of chronic venous insufficiency The device is intended for hospital, home and clinic use

Device Story

Phlebo Press DVT Model 760D is a pneumatic compression device consisting of a control unit and compression garments. It applies intermittent pneumatic compression to limbs to enhance venous blood flow and prevent venous stasis. Used in hospitals, clinics, or home settings by healthcare professionals or patients under medical supervision. The device operates by inflating and deflating compression sleeves to provide sequential or uniform pressure, aiding in DVT prevention, edema reduction, and wound healing. It serves as a mechanical prophylactic and therapeutic tool for venous conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pneumatic compression system comprising a control unit and inflatable limb garments. Operates via intermittent pneumatic compression. Designed for hospital, clinic, and home use. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients susceptible to deep vein thrombosis (DVT), patients requiring reduction of pain/swelling post-injury or surgery, enhancement of venous circulation, prevention of venous stasis, assistance in healing cutaneous ulcers, reduction of edema, and treatment of chronic venous insufficiency. Intended for use by healthcare 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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November 3, 2017

Mego Afek AC Ltd. Ilan Sharon A 109 Neot Golf Caesarea, 3088900 Il

Re: K172277

Trade/Device Name: Phlebo Press DVT Model 760D Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: August 3. 2017 Received: August 7, 2017

Dear Ilan Sharon:

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 of medical device-related adverse events) (21 CFR 803); 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.

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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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Nicole G. Ibrahim -S

for 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) K172277

Device Name Phlebo Press DVT Model 760D

## Indications for Use (Describe)

The Phlebo Press DVT Model 760D including compression garments is intended for use by healthcare 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
- · Reducing edema
- · Treatment of chronic venous insufficiency

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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