MINI SHOPPER

K013927 · Shoprider Intl., Inc. · INI · Jan 28, 2002 · Physical Medicine

Device Facts

• Record ID: K013927
• Device Name: MINI SHOPPER
• Applicant: Shoprider Intl., Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Jan 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To provide an optional means of mobility for physically challenged people.

Device Story

TE-787N Mini Shopper is a motorized three-wheeled vehicle; provides mobility assistance for physically challenged users. Device operates via manual controls; intended for personal transport. Benefits include increased independence for individuals with mobility impairments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized three-wheeled vehicle; Class II; Product Code INI; Regulation 890.3800.

Indications for Use

Indicated for physically challenged individuals requiring an optional means of mobility.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2007

Shoprider International, Inc. % Pillar Technology, Inc. Mr. Chris Tinsley, President P.O. Box 187 Neodesha, KS 66757

Re: K013927 Trade/Device Name: TE-787N Mini Shopper Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: November 19, 2001 Received: November 28, 2001

Dear Mr. Tinsley:

This letter corrects our substantially equivalent letter of January 28, 2002.

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 (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 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

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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 continue 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 (240) 276- 0120 or view their Internet address http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure. 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark N Melkman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Mini Shopper Device Name: _TE-787N___

Indications for Use:

Indications for Use.
To provide an optional means of mobility for physically challenged people.

(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

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

(k) Number. K013927 (Optional Format 1-2-96)