RP Lite 760R

K163280 · Mego Afek AC , Ltd. · IRP · Jan 27, 2017 · Physical Medicine

Device Facts

• Record ID: K163280
• Device Name: RP Lite 760R
• Applicant: Mego Afek AC , Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Jan 27, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RP Lite 760R is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas in people who are in good health. The RP Lite 760R simulates kneading and stroking of tissues by using an inflatable garment.

Device Story

RP Lite 760R is a powered inflatable tube massager; operates by inflating/deflating garments to simulate kneading and stroking of tissues. Used in home or clinical settings by healthy individuals for temporary muscle ache relief and circulation improvement. Device provides mechanical compression therapy; no complex software or AI algorithms involved. User controls inflation cycles to apply pressure to specific body areas. Benefits include non-invasive muscle relaxation and enhanced local blood flow.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Powered inflatable tube massager; pneumatic compression system; consists of control unit and inflatable garments. Operates via mechanical inflation/deflation cycles. Class II device (21 CFR 890.5650).

Indications for Use

Indicated for healthy individuals seeking temporary relief of minor muscle aches and temporary increase in blood circulation to treated areas.

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

January 27, 2017

Mego Afek AC Ltd. % Ilan Sharon Consultant Ilan Sharon Consultant Neot Golf A109 Caesarea, 3088900 Israel

Re: K163280

Trade/Device Name: RP Lite 760R Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: November 15, 2016 Received: November 21, 2016

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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" (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 at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

## Carlos L. Pena -S

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) K163280

Device Name RP Lite 760R

Indications for Use (Describe)

The RP Lite 760R is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas in people who are in good health.

The RP Lite 760R simulates kneading and stroking of tissues by using an inflatable garment.

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

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---------------|----------------------------------------------|---------------|---------------------------------------------|
| <span></span> | <span></span> | <b>X</b> | <span></span> |

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

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