YK9000 SERIES MANUAL WHEELCHAIR

K052468 · Intco Metal Products (Zhenjiang) Co., Ltd. · IOR · Oct 5, 2005 · Physical Medicine

Device Facts

• Record ID: K052468
• Device Name: YK9000 SERIES MANUAL WHEELCHAIR
• Applicant: Intco Metal Products (Zhenjiang) Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Oct 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

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.

Device Story

Manual wheelchair; provides mobility to persons restricted to sitting position. Consists of rigid aluminum alloy frame; leatherette upholstery; large rear wheels; smaller front casters for maneuverability. Operated by user or caregiver; used in clinical or home settings. Device facilitates patient mobility; improves independence.

Clinical Evidence

Bench testing only. Device performance verified against ISO 7176 standards (static stability, brake efficiency, static/impact/fatigue strength) and EN 1021-1 (upholstery ignitability).

Technological Characteristics

Aluminum alloy frame; leatherette upholstery. Manual operation. Complies with ISO 7176-1, 7176-3, 7176-8, 7176-11, 7176-15, 7176-16, and EN 1021-1. Class I mechanical device.

Indications for Use

Indicated for persons restricted to a sitting position requiring a manually operated device for mobility.

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

• Invacare Corporation Tracer SX, the Tracer series of Manual Wheelchair (K935398)

Submission Summary (Full Text)

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OCT 5 - 2005

K 052468

EXHIBIT #1 Page 1 of 2

# 510(K)SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in This summary of SMDA 1990 and 21 CFR \$807.92.

The assigned 510(k) number is:_

1. Submitter's Identification: Mr. Fangyi Liu Intco Metal Products (Zhenjiang) Co., Ltd. Into Metal Products (Zilenjiang) Co., Eto.
West Xinggang Rd. Dagang Zhenjiang, Jiangsu, China (Mechanical & Electrical Industrial Park) Date Summary Prepared: August 18,2005

2. Name of the Device: Intco Metal Products (Zhenjiang) Co., Ltd.

YK9000 Series Manual Wheelchair

3. Predicate Device Information and Substantial Equivalence:

5. Predicale Products (Zhenjiang) Co., I.id. YK9000 Series Manual Wheelchair is Inco Metal Troutets (Zacinang) Con-Characess to the Invacare Corporation Tracer SX. the Tracer series of Manual Wheelchair (K935398).

#### 4. Intended Use:

...

The intended use of Intco Metal Products (Zhenjiang) Co., Ltd. YK9000 Series Manual The intended ase of mices mobility to persons limited to a sitting position.

## 5. Device Description:

Classified by FDA's Physical Medicine panel as Class 1, 21 CFR 890.3850. Wheelchair (Mechanical), product code is ION. The Inteo Metal Products (Zhenjiang) Co., ( Wheelehalf (Mechaincar), produce chair is wheelchair that provides mobility to persons Itial. TK 7000 Series Manar "reonsist a rigid, mechanical, Aluminum Alloy frame and mithed to a sitting position: it consist of the Ignitability of Upholstered leatherette upholistery that moets EP .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . smaller front casters for turning and maneuverability.

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## 6. Technological Characteristics Summary:

The standards used for Inteo Metal Products (Zhenjiang) Co., Ltd. Wheelchair production are based on the following standards:

| ISO 7176-1 | Wheelchair: Determination of static Stability |
|-------------|---------------------------------------------------------------------------------------------|
| ISO 7176-3 | Wheelchair: Determination of efficiency of brakes |
| ISO 7176-8 | Wheelchair: Requirements and test methods for static, impact<br>and f fatigue strengths. |
| ISO 7176-11 | Wheelchair: Test dummies. |
| ISO 7176-15 | Wheelchair: Requirements for information disclosure. documentation and labeling. |
| ISO 7176-16 | Wheelchair: Resistance of ignition of upholstered parts -<br>Requirements and test methods. |
| EN 1021-1 | Furniture - Assessment of the Ignitability of Upholstered<br>Furniture. |

#### 7. Conclusion:

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Intco Metal Products (Zhenjiang) Co., Ltd. YK9000 Series Manual Wheelchair conform fully to the standards which be mentioned in Section 6 as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 6: There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

OCT 5 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intco Metal Products (Zhenjiang) Co., Ltd. c/o John Zhao Official Correspondent Basic Medical Industries, Inc. 12390 East End Avenue Chino, California 91710

Re: K052468

Trade/Device Name: YK9000 Series Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: September 13, 2005 Received: September 28, 2005

Dear Mr. Zhao:

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 bas 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 - John Zhao

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/dsma/dsmamain.html

Sincerely yours,

2

Mark N. Melkerson STY Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment A

Page 1 of 1

510(k) NUMBER (IF KNOWN) : Inteo Metal Products (Zhenjiang) Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: YK9000 Series Manual Wheelchair

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.

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

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

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

2

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

510(k) Number K052468