ASTROTILT MANUAL WHEELCHAIR

K061475 · Pdg Product Design Group, Inc. · IOR · Jun 14, 2006 · Physical Medicine

Device Facts

• Record ID: K061475
• Device Name: ASTROTILT MANUAL WHEELCHAIR
• Applicant: Pdg Product Design Group, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Jun 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

To provide mobility to individuals limited to a sitting position.

Device Story

Astrotilt Manual Wheelchair; provides mobility for individuals limited to sitting position. Device is manually operated by user or caregiver. Used in home, clinical, or community settings. Facilitates patient mobility and independence.

Technological Characteristics

Mechanical wheelchair; manual operation. Class I device per 21 CFR 890.3850.

Indications for Use

Indicated for individuals limited 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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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around the perimeter of the circle. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2006

PDG Product Design Group, Inc. % Underwriters Laboratories, Inc. Mr. Marc Mouser Senior Project Engineer 2600 N.W. Lake Road Camas, Washington 98607-8542

Re: K061475

Trade/Device Name: Astrotilt Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: May 25, 2006 Received: May 30, 2006

Dear Mr. Mouser:

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.

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. UDA max 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 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), please contact the Office of Compliance at [phone]. 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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): ___________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

To provide mobility to individuals limited to a sitting position.

Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Chauhan buchnut for MKM

(Division Sign-Off (Division Sign-Off-Off-Off-Orative,
Division of General, Restorative, Division of Division of Neurological Devices

510(k) Number_