RECOVERY PUMP 737R

K140519 · Mego Afek AC , Ltd. · IRP · Jun 16, 2014 · Physical Medicine

Device Facts

• Record ID: K140519
• Device Name: RECOVERY PUMP 737R
• Applicant: Mego Afek AC , Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Jun 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Recovery Pump 737R is an air compression therapy device intended to provide graduated pressure to compression gaments. The Recovery Pump 737R is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. The Recovery Pump 737R simulates kneading of tissues by using an inflatable garment.

Device Story

Recovery Pump 737R is a powered inflatable tube massager; provides graduated pneumatic compression to limbs via inflatable garments. Device simulates tissue kneading to promote circulation and relieve minor muscle aches/pains. Intended for use by healthy individuals. Operation involves pneumatic pump unit connected to garment; user controls pressure settings. Output is mechanical compression of treated area. Benefits include temporary relief of muscle discomfort and enhanced local blood flow. Used in home or clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered inflatable tube massager; pneumatic pump system; graduated compression delivery; inflatable garment interface; electrical energy source.

Indications for Use

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

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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

June 16, 2014

MEGO AFEK AC Ltd. Attn: Aharon Cohen, QA&R Manager Kibbutz Afek Afèk 30042 Israel

Re: K140519

> Trade Name: Recovery Pump 737R Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: March 17, 2014 Received: March 20, 2014

Dear Mr. Cohen:

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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## Page 2 of 2 – Mr. Aharon Cohen

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/ReportalProblem/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

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

## Indications for Use

510(k) Number (if known) K140519

#### Device Name

Recovery Pump 737R

#### Indications for Use (Describe)

The Recovery Pump 737R is an air compression therapy device intended to provide graduated pressure to compression gaments. The Recovery Pump 737R is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. The Recovery Pump 737R simulates kneading of tissues by using an inflatable garment.

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)

# Date: 2014.06.16 16:33:35 -04'00'

FORM FDA 3881 (1/14)

PSC Publishing Services (30) 443-6740 EF

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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