QUICKIE QX MANUAL FOLDING WHEELCHAIR

K072153 · Sunrise Medical, Inc. · IOR · Sep 10, 2007 · Physical Medicine

Device Facts

• Record ID: K072153
• Device Name: QUICKIE QX MANUAL FOLDING WHEELCHAIR
• Applicant: Sunrise Medical, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Sep 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The Sunrise Medical Quickie QX Manual Folding Mechanical Wheelchair's intended use is to provide mobility to persons restricted to a sitting position. The Quickie QX Manual Folding Wheelchair is a mechanical wheelchair that is a manually operated device with wheels that is intended for medical purposes which provides an optional means of mobility for physically challenged people. The mechanical wheelchair is indicated for physically challenged individuals and can provide a means of mobility

Device Story

Quickie QX Manual Folding Wheelchair is a manually operated mechanical wheelchair; provides mobility for individuals restricted to sitting position. Device features folding frame; intended for medical use by physically challenged persons. Operated by user or caregiver; used in home or clinical environments. Provides independent or assisted mobility; improves patient access to daily activities.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Mechanical manual folding wheelchair; frame construction; wheels; manual operation. No electronic components, software, or energy source. Class I device per 21 CFR 890.3850.

Indications for Use

Indicated for physically challenged individuals restricted to a sitting position requiring a manual wheelchair for mobility.

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

## SEP 1 0 2007

Sunrise Medical % Mr. Joseph E. Olsavsky, RAC VP-Global Quality & Regulatory 100 DeVilbiss Drive Somerset, PA 15501-2125

Re: K072153

> Trade/Device Name: Quickie QX Manual Folding Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: August 2, 2007 Received: August 7, 2007

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 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.

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Page 2 - Mr. Joseph E. Olsavsky, RAC

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely von

for Polo V
Mark N. Melkerson

Dr. Dassa
9/16/05

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 QX Manual Folding Wheelchair |
| Indications for Use: | The Sunrise Medical Quickie QX Manual Folding<br>Mechanical Wheelchair's intended use is to provide mobility<br>to persons restricted to a sitting position.<br><br>The Quickie QX Manual Folding Wheelchair is a mechanical<br>wheelchair that is a manually operated device with wheels<br>that is intended for medical purposes which provides an<br>optional means of mobility for physically challenged people<br><br>The mechanical wheelchair is indicated for physically<br>challenged individuals and can provide a means of mobility |

| Prescription Use__________<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use__________X<br>(Part 21 CFR 807 Subpart C) |
|-----------------------------------------------------------|--------|----------------------------------------------------------------|
|-----------------------------------------------------------|--------|----------------------------------------------------------------|

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

(Division Sign-Off)

Division of General, Restorative,

Concurrence of CDRH, Office of Device Evaluation (ODE)

| 510(k) Number__________ | 16072153 |
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| Page 1 of__________ |
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