Lympha Press Optimal Plus

K182003 · Mego Afek AC , Ltd. · JOW · Feb 27, 2019 · Cardiovascular

Device Facts

• Record ID: K182003
• Device Name: Lympha Press Optimal Plus
• Applicant: Mego Afek AC , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: - Primary lymphedema - · Secondary lymphedema - · Venous insufficiency - · Venous stasis ulcers - · Dysfunction of the muscle pump - · Post mastectomy edema - · Edema following trauma and sports issues - · Post immobilization edema - · Reducing wound healing time - · Reduction of pain and swelling after injury and surgery - · The device may also be beneficial in the management of Lipoedema The device is intended for hospital, home, and clinic use.

Device Story

Lympha Press Optimal Plus is a compressible limb sleeve device used in hospital, clinic, or home settings. It functions as a pneumatic compression system to treat edema and venous conditions. The device applies sequential pressure to limbs to assist fluid drainage and improve circulation. It is operated by medical professionals or patients under medical supervision. The output is the mechanical compression of the limb, which aids in reducing swelling, managing pain, and promoting wound healing. The device provides therapeutic benefits by mimicking the muscle pump function.

Technological Characteristics

Compressible limb sleeve (21 CFR 870.5800); pneumatic compression system; intended for hospital, home, and clinic use.

Indications for Use

Indicated for patients requiring treatment for primary/secondary lymphedema, venous insufficiency, venous stasis ulcers, muscle pump dysfunction, post-mastectomy edema, post-trauma/sports injury edema, post-immobilization edema, and lipoedema. Used for reducing wound healing time and managing pain/swelling post-injury or surgery. Intended 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".

February 27, 2019

Mego Afek AC Ltd. % Ilan Sharon Consultant P.O. Box 4414 (A109) Caesarea, 3088900 Il

Re: K182003

Trade/Device Name: Lympha Press Optimal Plus Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: January 20, 2019 Received: January 23, 2019

# 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Fernando Aguel Fernando Aguel - 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) K182003

Device Name Lympha Press Optimal Plus

#### Indications for Use (Describe)

The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:

- Primary lymphedema
- · Secondary lymphedema
- · Venous insufficiency
- · Venous stasis ulcers
- · Dysfunction of the muscle pump
- · Post mastectomy edema
- · Edema following trauma and sports issues
- · Post immobilization edema
- · Reducing wound healing time
- · Reduction of pain and swelling after injury and surgery
- · The device may also be beneficial in the management of Lipoedema

The device is intended for hospital, home, and clinic use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10pt;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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