MAXHEALTH MECHANICAL WHEELCHAIR, K1

K070176 · Maxhealth Corp. · IOR · Mar 1, 2007 · Physical Medicine

Device Facts

• Record ID: K070176
• Device Name: MAXHEALTH MECHANICAL WHEELCHAIR, K1
• Applicant: Maxhealth Corp.
• Product Code: IOR · Physical Medicine
• Decision Date: Mar 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Device Story

MAXHEALTH Mechanical Wheelchair, K1 is a manual, indoor/outdoor mobility device. Features a four-wheeled base, seat, and standard sling-style back/seat upholstery. Designed for portability, the device is foldable and can be disassembled for transport. Operated by the user or an assistant to provide mobility for individuals restricted to a seated position. Upholstery meets California Technical Bulletin CAL 117 flame retardant standards. Device provides patient benefit by restoring or facilitating independent or assisted mobility.

Clinical Evidence

Bench testing only. The device was evaluated for performance against ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. No clinical data provided.

Technological Characteristics

Mechanical wheelchair; four-wheeled base; foldable frame; sling-type seat and back upholstery. Upholstery meets California Technical Bulletin CAL 117 flame retardant standards. Performance tested per ANSI/RESNA WC vol. 1 and 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

• JAN MAO Wheelchair JMC612-FL318EPP (K062218)

Submission Summary (Full Text)

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K070176

Image /page/0/Picture/1 description: The image shows a logo for Maxhealth Medical Products. The logo features three stick figures with their arms raised, connected by a horizontal line. To the right of the stick figures, the text "Maxhealth" is written in a bold font, with the trademark symbol next to it. Below "Maxhealth", the text "User Friendly Medical Products" is written in a smaller font.

**MAXHEALTH CORPORATION**

15F-6, NO. 81. SEC 1, HSIN TAI WO RD., HSI CHIF
P.O. BOX 2-78, HSI CHIH, TAIPEI HSIEN, TAIWAN R.O.C.

TEL: [phone](Rep.)
FAX: [phone]
886-2-26982486

## 510(k) SUMMARY "

MAR 0 1 2007

January 10, 2007

Submitter's Name: MAXHEALTH CORP.

15F-6, No.81, Hsin Tai Wu Rd., Sec. 1, His Chih, Taipei Hsien, Taiwan, 22101. ROC

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

MAXHEALTH Mechanical Wheelchair, K1 Mechanical Wheelchair Mechanical Wheelchair, Class I, 21 CFR 890.3850

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Description of the device:

The MAXHEALTH Mechanical Wheelchair, K1 is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

Performance Testing:

MAXHEALTH Mechanical Wheelchair, K1 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Legally marketed device for substantial equivalence comparison:

JAN MAO Wheelchair JMC612-FL318EPP (K062218 )

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its head turned to the left and wings outstretched. The eagle is composed of three thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Maxhealth Corporation % Roc Chinese-Europe Industrial Research Society Jen Ke-Min No. 58, Fu-Chiun Street Hsin-Chu City China (Taiwan)

MAR 0 1 2007

Re: K070176

Trade/Device Name: MAXHEALTH Mechanical Wheelchair, K1 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: January 10, 2007 Received: January 18, 2007

Dear Jen Ke-Min:

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 - Jen Ke-Min

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,

Sincerely yours,

for
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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Image /page/3/Picture/0 description: The image shows the logo and contact information for Maxhealth Corporation. The logo includes a stylized graphic of three figures holding hands, along with the company name and the tagline "User Friendly Medical Products." The contact information includes the address: 15F-6, NO. 81, SEC 1, HSIN TAI WU RD., HSI CHIH, P.O. BOX 2-78, HSI CHIH, TAIPEI HSIEN, TAIWAN R.O.C., as well as the telephone and fax numbers: TEL: 886-2-2 and FAX: 886-2-2, and 886-2-2.

TEL: [phone](Rep.)
FAX: [phone]
886-2-26982486

## Indications for Use

510 (K) Number ( If Known ):

Device Name: MAXHEALTH Mechanical Wheelchair, K1

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

| Prescription Use __________ | AND/OR | Over-The-Counter Use √__________ |
|-----------------------------|--------|----------------------------------|
| (Part 21 CFR 801 Subpart D) | | (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 | |
| Page 1 of 1 | |
| 510(k) Number | K070176 |

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