AIR PRESS MASSAGER

K032505 · Telebrands Corp · IRP · Sep 24, 2003 · Physical Medicine

Device Facts

• Record ID: K032505
• Device Name: AIR PRESS MASSAGER
• Applicant: Telebrands Corp
• Product Code: IRP · Physical Medicine
• Decision Date: Sep 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Air Press Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people with good health. The Air Press simulates kneading and stroking of tissues by using an inflatable garment.

Device Story

The Air Press Massager is a powered inflatable tube massager designed for home use. It consists of an inflatable garment that applies mechanical pressure to the user's limbs. The device operates by inflating and deflating chambers within the garment to simulate the kneading and stroking of human tissues. This mechanical action is intended to provide temporary relief from minor muscle aches and pains and to temporarily increase local blood circulation. The device is operated by the user to manage their own muscle discomfort.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered inflatable tube massager; utilizes pneumatic inflation/deflation cycles to provide mechanical massage; intended for home use; Class II device (21 CFR 890.5650).

Indications for Use

Indicated for healthy individuals seeking temporary relief of minor muscle aches and pains and temporary increase in local circulation.

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 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2003

Telebrands Corporation c/o Donald Segal Buchanan Ingersoll 1776 K St., N.W., Suite 800 Washington, DC 20006-2365

Re: K032505

Trade/Device Name: Telebrand Air Press Massager Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: August 13, 2003 Received: August 13, 2003

Dear Mr. Segal:

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 (see 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 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Donald E. Segal

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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

l. Mark N. Milken

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

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for TeleBrands. The logo is in black and white, with the word "TELE" in a bold, stylized font that is partially obscured by a black rectangle with rounded corners. The word "Brands" is written in a more standard font to the right of "TELE", and there is a registered trademark symbol to the right of "Brands".

## Statement of Indications for Use

The Air Press Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people with good health. The Air Press simulates kneading and stroking of tissues by using an inflatable garment.

for Mark N Millikan

(Division Sign-Off) Division of General, Restorative and Neurological Devices KO3 2505

510(k) Number _