CIE FOLDAWAY WHEELCHAIR

K050345 · Carlsbad International Export, Inc. · IOR · Mar 29, 2005 · Physical Medicine

Device Facts

• Record ID: K050345
• Device Name: CIE FOLDAWAY WHEELCHAIR
• Applicant: Carlsbad International Export, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Mar 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The intended use is to provide mobility to persons limited to a sitting position, or who are unable to walk for long periods of time.

Device Story

CIE Foldable Wheelchair (Travel Companion) is a mechanical mobility aid designed for individuals with limited walking ability. Device provides seated transport; operated by user or caregiver. Used in various settings including home, clinic, or travel environments. Foldable design facilitates storage and portability. Device functions as a manual mechanical wheelchair to assist patient mobility and independence.

Clinical Evidence

No clinical data provided; device is a mechanical wheelchair subject to general controls.

Technological Characteristics

Mechanical wheelchair; foldable frame design; manual operation. No electronic components, software, or energy source.

Indications for Use

Indicated for individuals with limited mobility, including those restricted to a sitting position or unable to walk for extended periods.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2005

Mrs. Laura Meyer Carlsbad International Export, Inc. 1954 Kellogg Avenue Carlsbad, California 92008-6581

Re: K050345

Trade/Device Name: CIE Foldable Wheelchair (Travel Companion) Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 9, 2005 Received: March 9, 2005

Dear Mrs. Meyer:

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 - Mrs. Laura Meyer

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,

Stupt Rhodes

Miriam C. Provost, Ph.D. Acting 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

510 K Number K050345

Devise Name CIE Foldable Wheelchair ( Travel Companion )

Indications for use:

The intended use is to provide mobility to persons limited to a sitting position, or who are unable to walk for long periods of time.

Prescription use ( Part 21 CFR 801 Subpart D) and or

Over the Counter Use X (21 CFR 807 Subpart C)

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Concurrence of CDRH, office of Device Evaluation ( ODE

Styt Rhodes

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

K050345 510(k) Number__