GLORY

K994127 · Pillar Technology, Inc. · INI · Feb 3, 2000 · Physical Medicine

Device Facts

• Record ID: K994127
• Device Name: GLORY
• Applicant: Pillar Technology, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Feb 3, 2000
• 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

Glory is a mobility aid designed for physically challenged individuals. It functions as an optional means of transport to assist with patient mobility. The device is intended for use by patients requiring assistance with movement. It operates as a mechanical mobility solution. The healthcare provider or patient uses the device to facilitate physical navigation, potentially improving patient independence and quality of life.

Clinical Evidence

No clinical data provided; bench testing only.

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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes, suggesting movement or flight.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 3 2000 FEB

Mr. Chris Tinsley President Pillar Technology, Inc. 1101 Illinois P.O. Box 187 Neodesha, Kansas 66757

Re: K994127

> Trade Name: Glory Regulatory Class: II Product Code: INI Dated: December 6, 1999 Received: December 7, 1999

## Dear Mr. Tinsley:

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 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 (Premarket Approval), 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 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 action. In addition, FDA may publish further announcements 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.

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

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Page 2 - Mr. Chris Tinsley

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,

Mark Melkerss

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________ K994127

Device Name: Glory

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109) sion of General Restorative Devices 510(k) Number

(Optional Format 1-2-96)