MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS

K032731 · Turbo Wheelchair Co., Inc. · IOR · Oct 30, 2003 · Physical Medicine

Device Facts

• Record ID: K032731
• Device Name: MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS
• Applicant: Turbo Wheelchair Co., Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Oct 30, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic

Device Story

The Merlexicraft Series of Manual (Mechanical) Wheelchairs are mechanical mobility devices designed for patient transport. Operated by the patient or an assistant, these devices provide mobility for individuals with physical impairments. The device functions as a standard manual wheelchair, facilitating movement in clinical or home environments. It does not incorporate electronic or motorized components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical wheelchair; manual operation; no energy source; no software; no electronic components.

Regulatory Classification

Identification

A mechanical wheelchair is a manually 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 2003

Ms. Jane Hermes, DC President Turbo Wheelchair Company 76 Meridian Road Beaufort, SC 29907

Re: K032731

Trade/Device Name: Merlexicraft Series of Manual (Mechanical) Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: September 8, 2003 Received: September 11, 2003

Dear Ms. Hermes:

This letter corrects our substantially equivalent letter of October 30, 2003 regarding the device named above. The regulation number, 21.CFR 3825 and regulation name, Mechanical walker, were incorrectly listed. The correct regulation number and name are listed above.

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

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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 reguirements 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.

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 N. Milkman

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