SOLAX

K131302 · Dongguan Prestige Sporting Goods Co., Ltd. · INI · Nov 26, 2013 · Physical Medicine

Device Facts

• Record ID: K131302
• Device Name: SOLAX
• Applicant: Dongguan Prestige Sporting Goods Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Nov 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device Story

The SOLAX ZIPPY scooter is a motorized three-wheeled vehicle designed to provide mobility to disabled or elderly individuals. The device features a retractable platform, adjustable tiller, lead-acid battery, electric motor, and seat/backrest. The user operates the device via a tiller handlebar and a thumb-operated potentiometer throttle control to manage forward and reverse motion. Releasing the throttle engages an electromagnetic brake for deceleration and stopping. The scooter is designed to be retracted for transport in a car trunk. It is intended for use by the patient in both indoor and outdoor environments.

Clinical Evidence

Bench testing only. Compliance with ANSI/RESNA WC standards (Vol. I Sec. 7, 8, 21), CISPR 11, IEC 60335-2-29, IEC 60601-1, IEC 61000 series, ISO 7176 series (1-6, 9-11, 13-16), ISO 14971, and ISO 10993 series.

Technological Characteristics

Motorized three-wheeled vehicle; lead-acid battery powered; electromagnetic braking system; thumb-operated potentiometer throttle control; retractable platform design. Complies with ISO 10993 (biocompatibility) and various ISO 7176 (wheelchair/scooter performance) standards.

Indications for Use

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

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Predicate Devices

• SOLAX MOBIE scooter (K122749)

Submission Summary (Full Text)

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### K131302

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

#### Applicant

Name: Dongguan Prestige Sporting Goods Co., Ltd. Address: 316 Industry District, Qiaotou Area, Houjie Town, Dongguan City, Guangdong Province, 523950, China Contact person: Mr. Alex Wu, Marketing Director Tel: [phone] Fax: [phone] e-mail: [e-mail]

#### Date prepared: Oct. 10, 2013

#### Device

Trade name: SOLAX

Model: ZIPPY scooter

Common name: Electrical scooter

Classification name: Motorized three-wheeled vehicle

Medical specialty (Panel): Physical Medicine Device

Regulation number: 890.3800

Product Code: INI

Classification: Class II

#### Predicate device

Trade name: SOLAX Model: MOBIE scooter Manufacture: Dongguan Prestige Sporting Goods Co., Ltd. 510(k) number: K122749 Regulation number: 890.3800 Product Code: INI Classification: Class II

#### Intend use of device

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

NOV 26 2013

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#### Device description:

The ZIPPY scooter consists of a retractable platform which connects the two front wheels and two rear wheels, an adjustable tiller, a lead acid battery with an off-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. It can be retracted for transport in a car trunk.

The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.

#### Summary of non-clinical testing

The ZIPPY scooter complied with the requirements of ANSI/RESNA WC. Vol. I Sec. 7, Sec 8 and sec. 21, CISPR 11, IEC 60335-2-29, IEC 60601-1, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8, ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4. ISO 7176-5, ISO 7176-6, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 7176-16, ISO 14971, ISO 10993-1. ISO 10993-5, and ISO 10993-10.

#### Statement of substantial equivalence

The design and technological characteristics of the ZIPPY scooter is basically similar to the predicate device chosen. They have same intended use of a motor driven, indoor and outdoor transportation vehicle to provide mobility to a disabled or elderly person limited to a seated position.

There are minor differences between the devices including overall dimensions, distances between front wheels and pre-charging distance do not alter the intended use function and use of the device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not raise any questions as to the safety and effectiveness. Therefore the ZIPPY scooter is substantially equivalent to the MOBIE (K122749).

#### Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act. 21 CFR Part 807 and based on the information provided in this premarket notification, Dongguan Prestige Sporting Goods Co., Ltd. concludes that, ZIPPY scooter is substantially equivalent to predicate devices as described herein.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 26, 2013

Dongguan Prestige Sporting Goods Co., Ltd. c/o Ms. Junnata Chang 16F-2(16A), No. 462, Sec. 2 ChongDe Rd., Beitun Dist. Taichung 406 TAIWAN

Re: K131302

Trade/Device Name: SOLAX ZIPPY SCOOTER Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: October 10, 2013 Received: October 22, 2013

Dear Ms. Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device weferenced 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 that I Dri has intacted and regulations administered by other Federal agencies. You must or any I cooral sukatos and regarents, including, but not limited to: registration and listing (21

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Page 2 - Ms. Junnata Chang

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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K131302

Device Name: SQLAX ZIPPY SCOOTER

Indications For Use:

The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

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

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

(Please Do Not WRITE BELOW THIS LINE - Continue on Another PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S

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