Ballancer Gold, 1212

K190015 · Mego Afek AC , Ltd. · IRP · Mar 25, 2019 · Physical Medicine

Device Facts

• Record ID: K190015
• Device Name: Ballancer Gold, 1212
• Applicant: Mego Afek AC , Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Ballancer® Gold, Model 1212, is a powered inflatable tube massager. Device consists of a control unit and inflatable garments. System applies gradient pneumatic pressure to patient limbs or body areas. Operation involves inflation/deflation cycles to simulate kneading and stroking of tissues. Used in clinical or home settings; operated by patients or healthcare providers. Output is mechanical pressure application. Benefits include temporary circulation increase and relief of minor muscle aches and pains.

Technological Characteristics

Powered inflatable tube massager; pneumatic pressure system; consists of control unit and inflatable garments; Class II device (21 CFR 890.5650).

Indications for Use

Indicated for individuals seeking 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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March 25, 2019

Mego Afek AC Ltd. Ilan Sharon Official Correspondent P.O. Box 4414 (A109) Caesarea, 3088900, IS

## Re: K190015

Trade/Device Name: Ballancer® Gold, Model 1212 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: December 29, 2018 Received: January 3, 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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,

Vivek J. Pinto -S

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

Enclosure

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## Indications for Use

510(k) Number (if known) K190015

Device Name Ballancer® Gold, Model 1212

Indications for Use (Describe)

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

The Ballancer Gold is indicated for:

- · Simulate kneading and stroking of the tissues by use of an inflatable garment.
- · Temporary increase circulation in the 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)

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

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