QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS

K060531 · Sunrise Medical · ITI · Mar 17, 2006 · Physical Medicine

Device Facts

• Record ID: K060531
• Device Name: QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS
• Applicant: Sunrise Medical
• Product Code: ITI · Physical Medicine
• Decision Date: Mar 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quickie Rhythm & Groove Series Power Wheelchairs with Quickie/Delphi Controls intended use is to empower physically challenged individuals by providing a means of mobility.

Device Story

Power wheelchair providing mobility for physically challenged individuals. Device utilizes Quickie/Delphi controls to translate user input into motor-driven movement. Operated by the patient to navigate environments. Intended to improve patient independence and mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered wheelchair with electronic control system (Quickie/Delphi). Class II device under 21 CFR 890.3860. Product code ITI.

Indications for Use

Indicated for physically challenged individuals requiring a means of mobility.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 17 2006

Sunrise Medical c/o Mr. Joseph E. Olsavsky Director, Regulatory Affairs 100 DeVilbiss Drive Somerset, Pennsylvania 15501

Re: K060531

Trade/Device Name: QuickieRhythm & Groove Scries Power Wheelchairs with Ouickie/Delphi Controls Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: March 26, 2006 Received: March 31, 2006

Dear Mr. Olsavsky:

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, 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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Page 2 - Mr. Robert Nagel

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CNR 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/dsma/dsmamain.html

Sincerely yours,

Herbert Larner

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

Enclosure

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Section 5.0 Indications for Use Statement

## Indications for Use Statement

| 510(k) Number (if known): | Not yet assigned |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Quickie Rhythm & Groove Series Power Wheelchairs with<br>Quickie/Delphi Controls |
| Indications for Use: | The Quickie Rhythm & Groove Series Power Wheelchairs<br>with Quickie/Delphi Controls intended use is to empower<br>physically challenged individuals by providing a means of<br>mobility. |

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

Hubert Zemer CD
(Division Sign Off)

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

510(k) Number_k 06053/

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