NISSIN PEDIATRIC SERIES WHEELCHAIR

K063521 · Nissin Medical, Inc. · INM · Feb 5, 2007 · Physical Medicine

Device Facts

• Record ID: K063521
• Device Name: NISSIN PEDIATRIC SERIES WHEELCHAIR
• Applicant: Nissin Medical, Inc.
• Product Code: INM · Physical Medicine
• Decision Date: Feb 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3100
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The NISSIN Pediatric Series Wheelchair to be used to empower persons physically challenged to a sitting position by providing a means of mobility.

Device Story

Mechanical pediatric wheelchair; provides mobility for physically challenged users. Components include seat frame, backrest, cushion, footrest, and casters. Configurable to user needs via various sizes, shapes, and materials. Operated by user or caregiver. Manual device; no electronic or software components.

Clinical Evidence

Bench testing only. Compliance with ISO 7176 and FDA guidance for mechanical and powered wheelchairs demonstrated.

Technological Characteristics

Mechanical wheelchair; manual operation. Components: seat frame, backrest, cushion, footrest, casters. Materials vary by configuration. Complies with ISO 7176 standards.

Indications for Use

Indicated for physically challenged persons requiring a sitting position and a means of mobility.

Regulatory Classification

Identification

A mechanical chair is a manually operated device intended for medical purposes that is used to assist a disabled person in performing an activity that the person would otherwise find difficult to do or be unable to do. Examples of mechanical chairs include the following: A chair with an elevating seat used to raise a person from a sitting position to a standing position and a chair with casters used by a person to move from one place to another while sitting.

Predicate Devices

• Rodeo Models by Convaid (K032402)

Submission Summary (Full Text)

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## 510(k) Summary: NISSIN Pigleo Series Pediatric Wheelchair

# Summary of Safety and Effectiveness:

FEB -- 5 2007

| Submitted: | September 25, 2006 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Name of Firm:<br>Location: | NISSIN MEDICAL INDUSTRIES (NISSIN) Company, LTD<br>35-2 Gongen, Okimura,<br>Kitanagoya-shi, Aichi-Prefecture<br>481-8681, Japan |
| 510(k) U.S. Contact: | Takahiro Haruyama<br>3551 Voyager Street, Suite 102<br>Torrance, CA 90503<br>[phone] (Office)<br>[phone] (Fax) |
| Trade Name: | NISSIN Pediatric Wheelchair |
| Common Name: | Mechanical Wheelchair |
| Classification: | 21 CFR Part 890.3850 Mechanical Wheelchair |
| Device Product Code: | IOR |
| Substantially<br>Equivalent Device: | Rodeo Models by Convaid (K032402). |

#### Device Description:

The NISSIN Pediatric Series Wheelchair consists of typical components found on most wheelchairs, THE NOON T ourants offices , backrest, seat frame, cushion, footrest and casters. Many of these suon do patil harities, an a range of sizes, shapes, angles, forms, materials or coverings. Components and a allow the chairs to be configured to meet the specific desires and needs of the user.

#### Intended Use:

The NISSIN Pediatric Series Wheelchair to be used to empower persons physically challenged to a sitting position by providing a means of mobility.

### Summary of Safety and Effectiveness:

Data was provided that demonstrated compliance with the Guidance document for the preparation of premarket notification [510(k)] applications for mechanical and powered preparation of promation in thee-wheeled vehicles (July 26, 1995, reformatted 12/18/97). In addition, data was submitted that demonstrated compliance with ISO 7176. All issues of safety and effectiveness have been addressed.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nissin Medical Inc. % Takahiro Haruyama 3551 Voyager Court Suite 102 Torrance, California 90503

FEB - 5 2007

Re: K063521

Trade/Device Name: Nissin Pediatric Series Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: December 17, 2006 Received: January 18, 2007

Dear Takahiro Haruvama:

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 – Takahiro Haruyama

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

Mark N. Melkerson

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: K063521

Device Name: NISSIN Pediatric Series Wheelchair

Indications For use: The NISSIN Pediatric Series Wheelchair is intended to be used to empower persons physically challenged to a sitting position by providing a means of mobility.

| Prescription Use <b>X</b><br>(Part 21 CFR 801 Subpart D) | <div align="center">AND</div> Or | Over-The-Counter Use <b>X</b><br>(21 CFR 807 Subpart C) |
|----------------------------------------------------------|----------------------------------|---------------------------------------------------------|
|----------------------------------------------------------|----------------------------------|---------------------------------------------------------|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | 1063521 |
|---------------|---------|
|---------------|---------|

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