ZIP'R PC

K072224 · Global Fabtech Wheelchair (Shanghai) Co., Ltd. · ITI · Sep 21, 2007 · Physical Medicine

Device Facts

• Record ID: K072224
• Device Name: ZIP'R PC
• Applicant: Global Fabtech Wheelchair (Shanghai) Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Sep 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zip'r PC powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Device Story

The Zip'r PC is a battery-operated, motor-driven powered wheelchair designed for indoor and outdoor transportation. The device features a modular design that disassembles into two components—a seat frame and a body frame containing motors and a battery pack—to facilitate transport. It is operated by the user via an integrated controller. The device utilizes an intelligent regenerative electromagnetic braking system. It provides mobility to disabled or elderly individuals who are restricted to a seated position, offering a practical alternative for travel. The device includes safety features such as anti-tip wheels and a horn.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Powered wheelchair; DC 24V, 320W motors; Lead-Acid 12V x 33AH x 2 batteries; intelligent regenerative electromagnetic braking system; rear-wheel drive; solid tires; modular frame design; off-board 5 AMP automatic charger.

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring indoor and outdoor mobility assistance.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• CWD01 (K062888)

Submission Summary (Full Text)

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K072224

SEP 2 1 2007

# Global FabTech Wheelchair (Shanghai) Co., Ltd.

No. 318, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China TEL: [phone] FAX: [phone]

# 510(k) Summary

#### Device

Trade name: Zip'r PC powered wheelchair Common name: Powered wheelchair Classification name: Powered wheelchair Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3860 Product Code: ITI Classification: Class II

### Predicate devices

CWD01 (K062888) / EMG Technology Co. Ltd.

## Intend use of device

Zip'r PC powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.

## Device description:

The Zip'r PC powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.

#### Substantial equivalence:

The Zip'r PC powered wheelchair is substantially equivalent to the CWD01 (K062888) manufactured by EMG Technology Co. Ltd..

There are minor differences in performance specifications of the powered wheelchairs, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Global FabTech Wheelchair (Shanghai) Co., Ltd. believes that the Zip'r PC powered wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.

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l FabTech Wheelchair (Shanghai) Co.,
18, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China
TEL: [phone] FAX: [phone]

intended for medical purposes to provide
ility to persons restricted to a sitting posi CWD01 (K0628 ad-Acid 12V×35AH×2 'U foaming tire × 2 60W x DC24V × 2Pc numatic tire × 2 4V 5A, off-bo 6 kg ( 300 lb 30 mm (44.5 00 mm ( 35.4 50 mm ( 25.6 Dynamic Shar direct drive ﺔ ﺍﻟ ealed transaxle bled or elderly persons limited to a seated pos notor driven, indoor and outdoor transport 5 AMP (Automatic Type) off-b s with the intended use to provide mob 12V × 33AH × 2PG Solid tire × 2 P Solid tire × 2 Po Zip'r PC ad-Acid 6 kg (35 lbs)
OC 24V, 320 W, 2 Pcs 6 kg (300 lbs 020 mm (40) 30 mm (24" 90 mm (39" 70 mm (23 620mm (21' 609mm (24 PG VRI at overall weigl t overall heigl at overall dept t overall widt iximum loadi Rear wheel driv verall heigh verall lengt verall widt tended use lotor outpu Front whee Rear whee ontrolle Charge Batter

ubstantial equivalence comparison of the Zip'r PC and CW

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| Continuous) | The substantial equivalence comparison of the Zip'r PC and CWD01 | Zip'r PC | CWD01 (K062888) |
|-------------------------|------------------------------------------------------------------|------------------------------------------------|-----------------|
| Armrest | Fixed | Removable | |
| Break system | | Intelligent regenerative electromagnetic brake | |
| Braking distance | Forward: 1.4 m(56") at max speed | | |
| Net weight w<br>battery | 68 kg (150 lbs) | 83.5kg (183.7 lbs) | |
| Slope grade ability | 8 degree | 12 degree | |
| Per-charge distance | Up to 40 km (25 miles) | 40 km (24 miles) | |
| Maximum speed | Up to 6.4 km/hr (4 mph), variable | 5 km/h (3.2 mph) | |
| Turning radius | 0.51 m (20") | | |
| Maximum curb<br>height | 25 mm (1") | | |
| Suspension | Front: No, Rear: No | Cross brace | |
| Horn | Yes | Yes | |
| Anti-tip wheels | Yes | Yes | |

Global FabTech Wheelchair (Shanghai) Co., Ltd.

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Image /page/3/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 three stripes forming its wing and tail feathers. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

L ISEF 2 1 7007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Global FabTech Wheelchair (Shanghai) Co., Ltd. % Mr. Edward Dong No. 318, TianFu Rd. Jiuting Songjiang Shanghai, 201615, China

> K072224 Trade/Device Name: Zip'r PC Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 7, 2007 Received: August 10, 2007

Dear Mr. Dong:

Re:

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. Edward Dong

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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3. Device descriptive information

3.1 Statement of indication for use

# Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Zip'r PC

Indications for Use:

The Zip'r PC powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Over-The-Counter Use _ X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

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

**510(k) Number** K672224

(Posted November 13, 2003)