MECHANICAL DAILY USE WHEELCHAIR

K021075 · First World Services, Inc. · IOR · Jul 12, 2002 · Physical Medicine

Device Facts

• Record ID: K021075
• Device Name: MECHANICAL DAILY USE WHEELCHAIR
• Applicant: First World Services, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Jul 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The device is a mechanical wheelchair with wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.

Device Story

Mechanical daily use wheelchair; manually propelled by user. Provides mobility for individuals with physical handicaps restricted to sitting position. Operated by patient; used in home or clinical settings. Device consists of frame, seat, and manual wheels. No electronic components or software.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical wheelchair; manual propulsion; Class I device; Product Code IOR.

Indications for Use

Indicated for physically handicapped persons restricted to a sitting position who are capable of manually propelling the wheelchair.

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

JUL 12 2002

First World Services, Inc. c/o Mr. Leonard Frier MET Laboratories, Inc. 914 West Patapsco Avenue Baltimore, MD 21230

Re: K021075

Trade/Device Name: Mechanical Daily Use Wheelchair Regulation Number: 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: I Product Code: IOR Dated: June 25, 2002 Received: June 26, 2002

Dear Mr. Frier:

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. Leonard Frier

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Hyde Ruder

CeHa 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 Statement

510K number:

Device Name: Mechanical Daily Use Wheelchair

Indications For Use: The device is a mechanical wheelchair with wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Stypk Plurdy

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

510(k) Number_KO210 75

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use_X_