WELLNESS/JOLIVETE

K040905 · Tohkai Precision Ind. , Ltd. · IRP · Feb 23, 2005 · Physical Medicine

Device Facts

• Record ID: K040905
• Device Name: WELLNESS/JOLIVETE
• Applicant: Tohkai Precision Ind. , Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Feb 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

By individuals or clinicians, to provide temporary relief from localized aches, pains and / Dy in widdlers of calvisions, to provises caused by poor circulation, muscular stress or edema. May also be used to temporarily relieve symptoms of lymphoedema.

Device Story

Wellness/Jolivette Massage Booties are powered inflatable tube massagers; intended for OTC or clinician use. Device applies pneumatic compression to lower extremities to improve circulation and reduce edema/muscular stress. Operation involves inflation/deflation cycles to provide massage effect. Used for temporary relief of aches, pains, and lymphoedema symptoms. Patient benefits from improved circulation and symptom management.

Clinical Evidence

Bench testing only.

Technological Characteristics

Powered inflatable tube massager; pneumatic compression system; Class II device; Product Code IRP.

Indications for Use

Indicated for individuals or clinicians to provide temporary relief of localized aches, pains, and discomfort caused by poor circulation, muscular stress, or edema; also indicated for temporary relief of lymphoedema symptoms.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2005

Tohkai Precision Mfy, Ltd. C/o Robert T. Wagner President AEGIS. Inc. 2840 Scherer Drive North Saint Petersburg, Florida 33716

Re: K040905

Trade/Device Name: Wellness/ Jolivette Massage Booties Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP Dated: February 14, 2005 Received: February 14, 2005

Dear Mr. Wagner:

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.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act): 21 CFR 1000-1050.

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Page 2 - Mr. Wagner

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Wellness / Jolivette Massage Booties (Tohkai Precision Mfy, Itd., Hong Kong)

Indications for Use:

By individuals or clinicians, to provide temporary relief from localized aches, pains and / Dy in widdlers of calvisions, to provises caused by poor circulation, muscular stress or edema. May also be used to temporarily relieve symptoms of lymphoedema.

Prescription Use (21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K640905