HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4

K091482 · Danyang Huayi Medical Supply & Equipment Co, Ltd. · IOR · Jul 6, 2009 · Physical Medicine

Device Facts

• Record ID: K091482
• Device Name: HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4
• Applicant: Danyang Huayi Medical Supply & Equipment Co, Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Jul 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The Danyang Huayi K3/K4 wheelchair is indicated for providing mobility to persons limited to a sitting position.

Device Story

The Danyang Huayi K3/K4 is a mechanical, lightweight wheelchair designed to provide mobility to individuals restricted to a sitting position. The device features a rigid steel and aluminum frame with nylon upholstery. It is equipped with two 24-inch rear wheels and two 8-inch front casters to facilitate turning and maneuverability. The wheelchair is intended for use in both indoor and outdoor environments on smooth surfaces, such as standard flooring, concrete, or asphalt, provided the area is free of large obstacles and inclines do not exceed 9 degrees. It is a manual mobility aid operated by the user or an assistant.

Clinical Evidence

Bench testing only. The device underwent testing for static stability, brake efficiency, dimensions, and fatigue strength per ISO 7176 standards. Material safety was evaluated via in vitro cytotoxicity testing (ISO 10993-5) and flame retardance testing (California Technical Bulletin 117).

Technological Characteristics

Materials: Steel and aluminum frame, nylon upholstery. Standards: ISO 7176-1 (stability), ISO 7176-3 (brakes), ISO 7176-5 (dimensions), ISO 7176-8 (strength), ISO 7176-16 (ignition resistance), ISO 10993-5 (cytotoxicity), ASTM D751 (tensile strength), California Technical Bulletin 117 (flame retardance). Form factor: Manual wheelchair with 24" rear wheels and 8" front casters. No energy source or software.

Indications for Use

Indicated for persons limited to a sitting position requiring mobility assistance.

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

• American Bantex R07-16/18 Wheelchair (K915262)

Submission Summary (Full Text)

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K091482

JUL - 6.2009

Danyang Huayi Medical Equipment & Supply Co., LTD One Zhenxing Road, Yunyang Economical Development Zone, Danyang, 212300 CHINA Tele: 86511-86900809; Fax: [phone]

856.340.3572

831.300.3572

China Solution Consulting

3119 Brick Lane, Decatur, GA 30033

Mr. Jiuguang (Joe) Song, President

Danyang Huayi Medical Supply &

1 Zhenxing Road, Yunyang Economic

www.china-solution.com

[e-mail]

Danvang, Jiangsu Province

Mr. Tommy Tang, Manager

Equipment Co., LTD

Development Zone

CHINA 212300

86.511.86900879

86.511.86900807

May 10, 2009

Model: K3, K4

[e-mail]

Mechanical wheelchair

Wheelchair, mechanical

Physical Medicine device

Huayi Lightweight Wheelchair

## SECTION 5.0: SUMMARY OF SAFETY AND EFFECTIVENESS

### Submission Correspondent

- Address Tele Fax Contact Person Email
## Sponsor Information

Address

Contact person

- Tele Fax Email
Date Prepared

Trade Name

Common/Usual Name

Classification Name

Classification Number

Classification Panel

CDRH Code

IOR

890 3850

Regulatory Classification

Class I

## 5.1: Product Description

The Danyang Huayi K3/k4 wheelchair is a lightweight wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel and aluminum frame and nylon upholstery back and seat that meet ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Danyang Huayi K3/K4 wheelchair is intended for the use in indoors and outdoors, over smooth surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that free of large obstacles and inclines greater than 9 degrees.

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Image /page/1/Picture/0 description: The image shows a logo with a stylized symbol on the left and text on the right. The symbol appears to be two curved shapes enclosing a circle. To the right of the symbol, the text "HUAYE" is displayed in a bold, sans-serif font, with smaller Chinese characters beneath it. The overall impression is that of a corporate or brand logo, possibly for a company with both English and Chinese branding.

Danyang Huayi Medical Equipment & Supply Co., LTD One Zhenxing Road, Yunyang Economical Development Zone, Danyang, 212300 CHINA Tele: 86511-86900809; Fax: [phone]

#### Indication for Use 5.2

The Danyang Huayi K3/K4 wheelchair is indicated for providing mobility to persons limited to a sitting position.

#### Conformance to Standards 5.3 .

The Danyang Huayi K3/K4 wheelchair production meets the following standards:

- ISO 7176-1 Wheelchair: Determination of static stability .
- ISO 7176-3 Wheelchair: Determination of efficiency of brakes. 0
- ISO 7176-5: Determination of overall dimension, mass and turning o space.
- ISO 7176-7: Measurement of seating and wheel dimensions. .
- ISO 7176-8 Wheelchair: Requirements and test methods for static, ● impact and fatigue strengths.
- ISO 7176-11 Wheelchair: Test dummies �
- ISO 7176-13: Determination of friction of test surface. .
- ISO 7171-15 Wheelchair: Requirements for information disclosure, ● documentation and labeling.
- ISO 7171-16 Wheelchair: Resistance to ignition of upholstered . parts - requirements and test methods.
- ISO 10993-5-1999: Biological Evaluation of Medical Devices Part . 5: Test for in vitro Cytotoxicity.
- ASTM D751:89 Section 11 Procedure A Tensile Strength .
- Section A, Part I and Section D, Part II of California Technical . Bullentin 117 Requirements, Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling Materials Used in Upholstered Furniture.
- PVC leather/Nylon fabric/liner in accordance with: Section E part 1 o of California Technical Bullentin 117 Requirement, Test Procedure and Apparatus for Testing the Flame Retrardance of Resilient Filling Materials Used in Upholstered Furniture.

### Predicated Device: American Bantex R07-16/18 Wheelchair 5.4 (K915262)

#### Substantial Equivalence ર્સ્ડ

The Danyang Huayi K3/K4 lightweight wheelchair and American BantexRo7-16/18 Wheelchair (K915262) are substantially equivalent products in all areas impacting safety and effectiveness.

#### 5.6 Conclusion

The Danyang K3/K4 lightweight wheelchair raises no safety and efficiency issues or makes any claims that differ from the predicate device cited.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

## JUL - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Danyang Huayi Medical Supply & Equipment Company, Limited % Mr. Jiuguang Song Managing Director China Solution Consulting 3119 Brick Lane Decatur, Georgia 30033.

Re: K091482

Trade/Device Name: Danyang Huayi K3/K4 Lightweight Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: I Product Code: IOR Dated: May 17, 2009 Received: May 19, 2009

Dear Mr. Song:

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 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

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Page 2-Mr. Jiuguang Song

and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 510(k) Number (if known): K091482

510(x) ?
Device Name: Danyang Huayi K3/K4 lightweight wheelchair

# Indications for Use:

Indications Huayi K3/K4 lightweight wheelchair is indicated for providing mobility to persons limited to a sitting position.

Over-The-Counter Use_ AND/OR Prescription Use: Yes (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

.

(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 Sign-On)
Division of Surgical, Orthopedic, Division of Sweet and Restorative Devices

510(k) Number K09.1482