THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR

K990557 · Pdg Product Design Group, Inc. · IOR · Mar 22, 1999 · Physical Medicine

Device Facts

• Record ID: K990557
• Device Name: THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR
• Applicant: Pdg Product Design Group, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Mar 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The intended use of the device is in providing mobility to persons restricted to a sitting position.

Device Story

The Stellar Tilt is a manually operated wheelchair designed to provide mobility for individuals restricted to a sitting position. It functions as a standard manual wheelchair, allowing the user or a caregiver to maneuver the device. It is intended for use in various environments, including homes, clinics, and public spaces. By providing a stable, mobile seating platform, the device assists users in navigating their surroundings, thereby enhancing independence and mobility. The device is operated manually and does not require complex electronic interfaces or power sources.

Clinical Evidence

No clinical data provided; device is a Class I manually operated wheelchair.

Technological Characteristics

Manually operated wheelchair; mechanical construction; no electronic components or software.

Indications for Use

Indicated for persons restricted to a sitting position requiring mobility assistance.

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

MAR 2 2 1999

Mr. Phil Mundy President PDG Product Design Group 9165 Shaughnessy Street Vancouver, B.C. Canada V6P 6R9

Re: K990557 The Stellar Tilt, Manually Trade Name: Operated Wheelchair Requlatory Class: I Product Code: IOR Dated: February 5, 1999 February 22, 1999 Received:

Dear Mr. Mundy:

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 aqainst 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 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. Phil Mundy

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,

Celia M. Witton, Ph.D.

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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## 8.1.1 Statement of Indications for Use

510(K) Number (if known): k990557

Device Name: The Stellar Tilt Manually Operated Wheelchair

Indications for use:

The intended use of the device is in providing mobility to persons restricted to a sitting position.

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Concurrence of CHRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use \$\not\$