RASCAL POWER CHAIR

K972370 · Electric Mobility Corp. · ITI · Nov 14, 1997 · Physical Medicine

Device Facts

• Record ID: K972370
• Device Name: RASCAL POWER CHAIR
• Applicant: Electric Mobility Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Nov 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Electric Mobility RASCAL Power Wheelchair is intended to serve the needs of individuals who have very limited mobility and a reduced capacity to steer or maneuver a wheelchair without some type of power assistance. While this product is specifically targeted to the outdoor market, its design is adaptable for indoor use as well. It is substantially equivalent to several power chairs currently on the market as described later in this application. It is extremely stable and durable and it is designed to carry up to 250 pounds on our standard unit and 400 pounds on our heavy duty unit. It is capable of operating over smooth indoor surfaces, or moderately rough, moderately soft, and uneven outdoor surfaces. It is capable of negotiating small obstacles and its spring suspension provides for a smooth ride and easier handling.

Device Story

RASCAL Power Wheelchair provides motorized mobility for individuals with limited physical capacity. Device features spring suspension for stability and handling over indoor surfaces and moderately rough/uneven outdoor terrain. Standard unit supports up to 250 lbs; heavy-duty unit supports up to 400 lbs. Operated by the user via power controls to navigate environments and negotiate small obstacles. Benefits include increased independence and mobility for users unable to operate manual wheelchairs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Power-driven wheelchair with spring suspension system. Supports weight capacities of 250 lbs (standard) and 400 lbs (heavy duty). Designed for indoor/outdoor operation on varied surfaces.

Indications for Use

Indicated for individuals with limited mobility and reduced capacity to steer or maneuver a manual wheelchair, requiring power assistance. Suitable for indoor and outdoor use on smooth, moderately rough, soft, or uneven surfaces.

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 - USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 1997

Mr. Lee J. Falgoust Director of Engineering Electric Mobility 1 Mobility Plaza Sewell, New Jersey 08080

K972370 Re: RASCAL Power Wheelchair Regulatory Class: II ITI Product Code: Dated: September 22, 1997 September 24, 1997 Received:

Dear Mr. Falgoust:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes-compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Lee J. Falgoust

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colia M. Witton Ph. D. M

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use

The Electric Mobility RASCAL Power Wheelchair is intended to serve the needs of individuals who have very limited mobility and a reduced capacity to steer or maneuver a wheelchair without some type of power assistance. While this product is specifically targeted to the outdoor market, its design is adaptable for indoor use as well. It is substantially equivalent to several power chairs currently on the market as described later in this application. It is extremely stable and durable and it is designed to carry up to 250 pounds on our standard unit and 400 pounds on our heavy duty unit. It is capable of operating over smooth indoor surfaces, or moderately rough, moderately soft, and uneven outdoor surfaces. It is capable of negotiating small obstacles and its spring suspension provides for a smooth ride and easier handling.

**Over-the-Counter Use** X

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Division Sign-Off) Ivision of General Restorative Devic 510(k) Number