JUMAO MANUAL WHEELCHAIR

K082784 · Danyang Jumao Healthcare Equipment Co., Ltd. · IOR · Oct 7, 2008 · Physical Medicine

Device Facts

• Record ID: K082784
• Device Name: JUMAO MANUAL WHEELCHAIR
• Applicant: Danyang Jumao Healthcare Equipment Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Oct 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The Jumao Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.

Device Story

Jumao Manual Wheelchair is a foldable, four-wheeled indoor/outdoor mobility device. It features a seat and backrest constructed from ignitability-resistant fabric. The device is designed for manual operation by the user or an attendant to provide mobility for individuals restricted to a seated position. It is intended for use in various environments, including homes and clinics. The device is collapsible for transport. It functions as a standard mechanical wheelchair without electronic or automated components.

Clinical Evidence

Bench testing only. The device demonstrated compliance with ISO 7176 standards for performance, consistent with the predicate device.

Technological Characteristics

Manual four-wheeled wheelchair; foldable frame; ignitability-resistant upholstery fabric. No electronic components or software. Performance testing conducted per ISO 7176 standards.

Indications for Use

Indicated for persons restricted to a seated 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

• Universal Wheelchair by Graham-Field Health Products, Inc. (K930411)

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 0 7 2008

Image /page/0/Picture/1 description: The image contains a handwritten text string that appears to read "K08a784". The characters are written in a somewhat stylized manner, with some variations in stroke thickness and letter formation. The text is presented against a plain white background.

#### CHAPTER 5. 510(K) SUMMARY

This 510(k) summary of safety and effectiveness for Jumao Manual Wheelchair is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

| Applicant: | Danyang Jumao Healthcare Equipment Co., Ltd. |
|----------------------|-----------------------------------------------------------------|
| Address: | No.89 Shuangfeng Road, Jiepai town, Danyang, Jiangsu, P.R.China |
| Contact Person: | Qing Wang |
| Telephone: | (86 511)- 86379811 |
| Email: | [e-mail] |
| Date of Preparation: | July 28, 2008 |
| Device Name: | JUMAO MANUAL WHEELCHAIR |
| Classification Name: | Manual Wheelchair |
| Device Class: | Class I |
| Product Code: | IOR |
| Classification Panel | Physical Medicine |
| Type of submission | Traditional 510K |

# Table 5-1 General Information

### Intended use:

The Jumao Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.

## Indications for Use:

The Jumao Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position. Jumao Manual Wheelchair is not designed, sold, or intended for use except as indicated.

# Device Description

The Jumao Manual Wheelchair is an indoor/outdoor wheelchair that has a base with four-wheels with a seat. The device can be disassembled for transport and it is foldable easily. Both the back and seat upholstery material is the same resistance-ignitability fabric.

All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in Predicate Device.

#### Predicate Device:

ﻬﺎ ﻓﻬﻮ: ﻳﻬﺎﺟﻪ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﺘﻲ ﺗﻬﺪﻑ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ

Universal Wheelchair by Graham-Field Health Products, Inc. (Formerly Everest & Jennings), 510(k) K930411.

{1}------------------------------------------------

Substantial Equivalence Information:

## Technological/Safety Characteristics:

The Jumao Manual Wheelchair's technological and safety characteristics are identical to those described in the Predicated Device. The detailed comparison table is included in Chapter 10.

#### Performance Data:

The Jumao Manual Wheelchair's performance is shown to comply with the relevant ISO 7176 standards, identical to those described in the Predicated Device.

# Conclusion:

The data submitted in this 510(K) Premarket Notification supports the finding that this device is substantially equivalent with respect to the intended use, technology, functionality, and safety features to the legally marketed Predicate Device. Therefore, we believe that this device meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(K) guidelines.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

OCT 0 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Danyang Jumao Healthcare Equipment % Regulatory Technology Services, I.L.C Mr. Mark Job 1394 25" Street, NW Buffalo, MN 55313

Re: K082784

Trade/Device Name: Jumao Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 22, 2008 Received: September 23, 2008

Dear Mr. Job:

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

{3}------------------------------------------------

Page 2 - Mr. Mark Job

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 100-1050. This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10(x) marketed predicate device results in a classification for your device and thus, permitts 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliar, at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance awelms at [phone]. You may obtain other general information on your remonsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances 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. Millman

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

Enclosure

{4}------------------------------------------------

#### CHAPTER 4. INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Jumao Manual Wheelchair

Indications for Use: ক্তু

The Jumao Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rizal Luma Decena to tata

ign-Of Division of General, Restorative, and Neurological Devices

**510(k) Number** L082784