Y.E.S 10 WHEELCHAIR

K021255 · Movingpeople.Net · ITI · May 2, 2002 · Physical Medicine

Device Facts

• Record ID: K021255
• Device Name: Y.E.S 10 WHEELCHAIR
• Applicant: Movingpeople.Net
• Product Code: ITI · Physical Medicine
• Decision Date: May 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The intended use of the movingpeople.net Y•e•S is to provide mobility to persons limited to a seated position and that have the capability of operating a powered wheelchair.

Device Story

Y.e.S is a powered wheelchair designed to provide mobility to individuals with limited physical capacity who remain in a seated position. The device functions as a standard powered wheelchair, allowing the user to control movement via an integrated interface. It is intended for use by the patient to facilitate independent navigation. The device operates as a mobility aid, assisting users in daily activities by providing motorized transport.

Clinical Evidence

No clinical data provided; substantial equivalence based on device classification and intended use.

Technological Characteristics

Powered wheelchair; Class II device (21 CFR 890.3860); Product Code ITI.

Indications for Use

Indicated for persons limited to a seated position who possess the capability to operate a powered wheelchair.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Movingpeople.net c/o Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891

Re: K021255

Trade/Device Name: Y.e.S Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: April 18, 2002 Received: April 19, 2002

Dear Mr. Job:

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.

MAY 022002

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. Mark Job

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,

for Martin M. Melkerson

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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K021255

Page .

510(k) Number (if known): Kozl 乙SS

Device Name: Y·e·S

Indications For Use:

| FDA/CDRH/ODE/DMC |
|------------------|
| RECEIVED |
| 19 2 29 PM '02 |

The intended use of the movingpeople.net Y•e•S is to provide mobility to persons limited to a seated position and that have the capability of operating a powered wheelchair.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109) or

Over-The-Counter Use _X (Optional format 1-2-96)

Mark N Millican

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

SK34

510(k) Number _