WHEELCHAIR MODEL STS

K071390 · Innovative Products, Inc. · IPL · Jul 20, 2007 · Physical Medicine

Device Facts

• Record ID: K071390
• Device Name: WHEELCHAIR MODEL STS
• Applicant: Innovative Products, Inc.
• Product Code: IPL · Physical Medicine
• Decision Date: Jul 20, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use of the Model STS Pediatric powered wheelchair is to provide mobility to children and young adults, weighing up to 150 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

Device Story

Pediatric powered wheelchair designed for mobility; provides sit-to-stand functionality. Input: user-operated standard joystick hand control. Operation: powered mechanism enables transition between sitting and standing positions. Output: physical mobility and postural change. Used in home or clinical environments by pediatric patients. Benefits: facilitates independent mobility and postural variation for children/young adults with limited mobility; improves quality of life through increased accessibility and functional independence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered standup wheelchair; joystick-controlled electric drive system. Designed for pediatric use (up to 150 lbs). Class II device (21 CFR 890.3900).

Indications for Use

Indicated for children and young adults weighing up to 150 lbs requiring mobility assistance. Patients must possess the physical ability to transition to a sitting position and the cognitive/motor capacity to operate a standard joystick hand control.

Regulatory Classification

Identification

A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

Submission Summary (Full Text)

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JUL 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innovative Products, Inc. % Mr. Jim Steinke President 830 South 48th Street Grand Forks, North Dakota 58201-9985

Re: K071390

> Trade/Device Name: Innovative Products Pediatric Sit to Stand Wheelchair Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: Class II Product Code: IPL Dated: June 2, 2007 Received: July 9, 2007

Dear Dr. Steinke:

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. Jim Steinke

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 yours.

Sincerely yours,

Mark A. Miller

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 Statement

510K number:

Device Name: Innovative Products Pediatric Sit to Stand Wheelchair

Indications for Use: The intended use of the Model STS Pediatric powered wheelchair is to provide mobility to children and young adults, weighing up to 150 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BEL、V THIS LANE-CONTINUE ON ANOTHER PAGE IF NEEDED) ﯿﺎ ﮨﮯ

Concurrence of CDRH/ Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K08351 |
|---------------|--------|
|---------------|--------|

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