F-10 FOLDING POWER CHAIR

K032441 · Wheelchair & Scooter Express · ITI · Oct 6, 2003 · Physical Medicine

Device Facts

• Record ID: K032441
• Device Name: F-10 FOLDING POWER CHAIR
• Applicant: Wheelchair & Scooter Express
• Product Code: ITI · Physical Medicine
• Decision Date: Oct 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To provide an optional means of mobility for physically challenged people.

Device Story

F-10 Folding Power Chair provides mobility for physically challenged users. Device functions as a powered wheelchair; allows user-controlled navigation via integrated controls. Used in various environments for personal mobility; assists individuals with physical limitations in daily activities. Operates as a standard powered wheelchair; no complex software or algorithmic processing described.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered wheelchair; folding frame design; electric motor propulsion; standard manual/powered wheelchair control interface. No software or complex electronic algorithms described.

Indications for Use

Indicated for physically challenged individuals requiring an optional means of mobility.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chris Tinsley Wheelchair & Scooter Express 4905 - A San Jacinto Houston, Texas 77004

Re: K032441

Trade/Device Name: F-10 Folding Power Chair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: July 28, 2003 Received: August 12, 2003

Dear Mr. Tinsley:

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 (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.

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Page 2 - Mr. Chris Tinsley

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/dsma/dsmamain.html

Sincerely yours,

Mark A. Millman

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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510 (k) Number (if known):

Device Name: F-10 Folding Power Chair

Indications for Use: To provide an optional means of mobility for physically challenged people.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Mark N. Mulkern
Division Sign Off

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

510(k) Number K032441
(Optional Format 1-2-96