Ballancer 505 System, Model 1201-AC

K150269 · Mego Afek AC , Ltd. · IRP · May 26, 2015 · Physical Medicine

Device Facts

• Record ID: K150269
• Device Name: Ballancer 505 System, Model 1201-AC
• Applicant: Mego Afek AC , Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: May 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied. The Ballancer 505 System is indicated for: * Simulating kneading and stroking of the tissues by use of an inflatable garment * Temporary increase circulation in areas which the garment is applied * Temporary relief of minor muscle aches and pains

Device Story

Ballancer 505 System (Model 1201-AC) is a pneumatic massage device; provides gradient pressure to body areas via inflatable garments. Operates by inflating/deflating garment chambers to simulate kneading and stroking of tissues. Used for temporary relief of minor muscle aches/pains and temporary increase in local circulation. Intended for both prescription and over-the-counter use. Device consists of a control unit and compatible inflatable garments. User selects settings to control pressure and cycle; device delivers mechanical compression to the patient. Benefits include muscle relaxation and improved circulation in treated areas.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered inflatable tube massager; consists of a control unit and inflatable garments. Operates via pneumatic pressure delivery. Class II device, product code IRP.

Indications for Use

Indicated for individuals requiring temporary relief of minor muscle aches and pains and temporary increase in circulation via simulated tissue kneading and stroking using an inflatable garment.

Regulatory Classification

Identification

A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

Submission Summary (Full Text)

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

May 26, 2015

Mego Afek AC Ltd. Mrs. Liat Winter OA and RA Manager Kibbutz Afek, 3004200 Israel

Re: K150269

> Trade Name: Ballancer® 505 System, Model 1201-AC Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: April 20, 2015 Received: April 23, 2015

Dear Mrs. Winter:

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Felipe Aquel -S

Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K150269

Device Name

Ballancer 505 System, Model 1201-AC

Indications for Use (Describe)

Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.

The Ballancer 505 System is indicated for:

* Simulating kneading and stroking of the tissues by use of an inflatable garment

* Temporary increase circulation in areas which the garment is applied

* Temporary relief of minor muscle aches and pains

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

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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