SKIPPI POWERED WHEELCHAIR FOR CHILDREN

K070318 · Otto Bock Healthcare LP · ITI · May 11, 2007 · Physical Medicine

Device Facts

• Record ID: K070318
• Device Name: SKIPPI POWERED WHEELCHAIR FOR CHILDREN
• Applicant: Otto Bock Healthcare LP
• Product Code: ITI · Physical Medicine
• Decision Date: May 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Skippi is a rear wheel drive powered wheelchair with caster front wheels for indoor use (primarily) but can be used outdoors as well. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the Curtis Instruments enAble 40 that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheels.

Device Story

Rear-wheel drive powered wheelchair for children/small users (up to 110 lbs); rigid 'H' frame; independent suspension on all four wheels. Input: user-operated joystick/controller (Curtis Instruments enAble 40). Transformation: controller signals two 24V DC motors (Micro Motor AG PMGST 76/40) to drive rear wheels at differential speeds for steering. Output: physical mobility. Used in indoor/outdoor settings; operated by patient or attendant (via optional control). Benefits: provides independent mobility for physically challenged users. Options include seat tilt, backrest adjustment, and tray.

Clinical Evidence

Bench testing only. Device tested by TÜV Product Service to EN 12184, ISO 7176 series, and ANSI/RESNA WA Vol. 2 Section 21 (EMC). Results confirmed fulfillment of all requirements.

Technological Characteristics

Rigid 'H' frame; 12.5-inch knobby rear tires; independent four-wheel suspension. Powered by two 24V DC motors (Micro Motor AG PMGST 76/40). Controller: Curtis Instruments enAble 40. Standards: EN 12184, ISO 7176, ANSI/RESNA WA Vol. 2 Section 21.

Indications for Use

Indicated for physically challenged persons limited to sitting positions requiring mobility assistance. Suitable for children or small people up to 110 lbs.

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.

Predicate Devices

• A-200 (K052706)

Submission Summary (Full Text)

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Otto Bock®

K070318

MAY 1 1 2007

## 510(k) SUMMARY of SAFETY and EFFECTIVENESS

## A. General Information

B.

| 1. | Submitter's Name: | OTTO BOCK HealthCare LP |
|--------|----------------------|-----------------------------------------------------------------|
| 2. | Address: | Two Carlson Parkway N., Suite 100<br>Minneapolis, MN 55447-4467 |
| 3. | Telephone: | 763-253-5607 |
| 4. | Contact Person: | Shannon Tufvander |
| 5. | Date Prepared: | January 18, 2007 |
| 6. | Registration Number: | 2182293 |
| Device | | |
| 1. | Name: | Skippi Powered Wheelchair for Children |
| 2. | Trade Name: | Skippi Powered Wheelchair for Children |
| 3. | Common Name: | Powered wheelchair |

4. Classification Name: Powered wheelchair

ITI 5. Product Code:

- 6. Class: II
- 7. Regulation Number: 890.3860

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Otto Bock®

## C. Identification of Legally Marketed Devices

| 1. Name: | A-200 |
|------------------|-------------------|
| 2. K Number: | K052706 |
| 3. Date Cleared: | December 27, 2005 |

#### D. Description of the Device

The Skippi is propelled by two DC Motors, Micro Motor AG PMGST 76/40 L/R 6 Km/H at 24 Volts. The controller is the enAble 40 manufactured by Curtis Instruments, AG.

The closed "H" frame is rigid (not foldable), all four wheels are suspended independently. The Skippi has 12.5 inch knobby rear tires.

Options available to the end user are the following:

- Seat Tilt Mechanism, Electric or with Gas Compression Spring .
- Electric Backrest Angle Adjustment .
- Seating Shell Adapter .
- . Tray
- . Control for Attendant
- . Bumper Bar
- Single Panel Footrest .
- Colors (Yellow, Blue, or Red) .

#### E. Intended Use Statement

The Skippi is a rear wheel drive powered wheelchair with caster front wheels for indoor use (primarily) but can be used outdoors as well. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the Curtis Instruments enAble 40 that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheels.

### F. Technological Characteristics Summary

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Otto Bock®

QUALITY FOR LIF

The Skippi Wheelchair is substantially equivalent to the OTTO BOCK A-200 Wheelchair, cleared on December 27, 2005 as K052706.

Each wheelchair is a powered wheelchair for the active user, with a rigid frame and similar characteristics. The Skippi is for children or small people up to 110 pounds, whereas the A-200 is for anyone up to 200 pounds.

The Skippi was tested by TÜV Product Service to the following standards:

- . EN 12184
- ISO 7176 -- Series .
- ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC .

with the conclusion that "the test sample fulfills the requirements."

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct, curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 1 2007

OTTO BOCK HealthCare, LP % Mr. William Jackson Regulatory Consultant 2247 Jennifer Lane St. Paul, Minnesota 55109-2851

Re: K070318

Trade/Device Name: Skippi Powered Wheelchair for Children Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: April 18, 2007 Received: April 27, 2007

Dear Mr. Jackson:

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. William Jackson

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 vor

for
Mark N. Melkerson
Romm 5/16/07

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): To be determined

Device Name: Skippi Powered Wheelchair for Children

Indications for Use:

- Provide mobility to persons physically challenged and limited to sitting positions. �
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH Office of Deyice uation (ODE)

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

**510(k) Number** K070318

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