NISSIN SERIES MECHANICAL WHEELCHAIR
Device Facts
| Record ID | K052521 |
|---|---|
| Device Name | NISSIN SERIES MECHANICAL WHEELCHAIR |
| Applicant | Nissin Medical Industries Co., Ltd. |
| Product Code | IOR · Physical Medicine |
| Decision Date | Sep 26, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3850 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Indications for Use
The NISSIN series Mechanical Wheelchair is intended to be used to empower persons physically challenged to a sitting position by providing a means of mobility.
Device Story
NISSIN series Mechanical Wheelchair; manual mobility device for physically challenged individuals. Components include push handles, armrests, backrest, seat frame, cushion, footrest, and casters. Configurable in various sizes, shapes, and materials to meet user needs. Operated by user or caregiver; intended for general mobility support. Provides physical mobility to patients restricted to sitting positions.
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 include push handles, armrests, backrest, seat frame, cushion, footrest, and casters. Materials vary by configuration. Complies with ISO 7176 standards.
Indications for Use
Indicated for persons restricted to a sitting position requiring mobility assistance for medical purposes.
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.
Predicate Devices
- Quickie Suspension Wheelchair Series Model XTR by Sunrise Medical (K982989)
Submission Summary (Full Text)
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K05-252/
## SEP 2 6 2005
510(k) Summary: NISSIN Mechanical Wheelchair
## Summary of Safety and Effectiveness:
| Submitted: | September 7, 2005 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Firm: | NISSIN MEDICAL INDUSTRIES (NISSIN) Company, LTD<br>Darren Reeves, U.S. Agent<br>Location: 8-7 Hanenishi<br>Yoyohasi, Aichi-Prefecture, Japan |
| 510(k) Contact: | Darren Reeves<br>866-393-4954 |
| Trade Name: | NISSIN series Mechanical Wheelchair |
| Common Name: | Mechanical Wheelchair |
| Classification: | 21 CFR Part 890.3850 Mechanical wheelchair |
Device Product Code: IOR.
#### Substantially
Quickie Suspension Wheelchair Series Model XTR by Sunrise Equivalent Device: Medical (K982989)
### Device Description:
The NISSIN series Mechanical Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Many of these components are available in a range of sizes, shapes, angles, forms, materials or coverings. Theses variations allow the chairs to be configured to meet the specific desires and needs of the user.
### Intended Use:
The NISSIN series Mechanical Wheelchair is intended 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 wheelchairs, and motorized three-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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.
SEP 26 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nissin Medical Industries Company, LTD c/o Mr. Darren Reeves DP Distribution & Consulting 15637 Fox Cove Circle Moseley, Virginia 23120
Re: K052521
Trade/Device Name: Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: September 12, 2005 Received: September 14, 2005
Dear Mr. Reeves:
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. Darren Reeves
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to ogain maining of substantial equivalence of your device to a legally prematicated 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 If you desire specific aarroliance at (240) 276-0120. Also, please note the regulation entitled, Coniact the Office of Computer in the time (21CFR Part 807.97). You may obtain Misoranding of Tereferee to presence to presentibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
ZS
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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# Indications for Use
ので、
the submit and the submit of the sub-
510(k) Number (if known): K052521
Device Name: Mechanical Wheelchalr
Indications For Use:
Intended for medical purposes to provide mobility to persons restricted to a sitting position
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR .
Over-The-Counter Use (21 CFR 807 Subpart C)
(Registration and Listing are submitted and in process)
(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
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