HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33

K071007 · Heartway Medical Products Co., Ltd. · INI · Apr 19, 2007 · Physical Medicine

Device Facts

• Record ID: K071007
• Device Name: HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33
• Applicant: Heartway Medical Products Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Apr 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

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

Device Story

The HEARTWAY S33 is a battery-operated, three-wheeled electric mobility scooter for indoor/outdoor use. The rider operates the device via hand controls located on the steering column. It features a seat, armrests, and a front basket; the unit is designed to be disassembled for transport. The device includes an onboard battery charger. It provides mobility to individuals restricted to a seated position, enhancing independence. Safety is maintained through adherence to specified incline limits and operational guidelines provided in the owner's manual.

Clinical Evidence

Bench testing only. Performance testing included EMC and electrical safety testing per ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-3-2:1995, and IEC61000-3-3:1995. Materials passed strength, fatigue, and ignition resistance testing.

Technological Characteristics

Three-wheeled motorized vehicle; battery-operated electric propulsion. Components include electronic controller, batteries, and switches. Complies with ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, and IEC61000-3-3 standards. Disassemblable form factor.

Indications for Use

Indicated for persons restricted to a seated position requiring mobility assistance.

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

• WU'S 3-WHEELED NEO SCOOTER, WT-T3D (K032488)

Submission Summary (Full Text)

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**HEARTWAY MEDICAL PRODUCTS CO.,LTD.**
NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408

b: www.heartway.com.tw

mail : [e-mail]

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K071007

April 4, 2007

PR 1 9

#### 510(k) SUMMARY " 66

Submitter's Name: HEARTWAY Medical Products Co., Ltd. No.6, Road 25, Taichung Industrial Park, Taichung, 408, Taiwan, ROC

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

HEARTWAY Lightweight Power Mobility Scooter, S33 POWERED SCOOTER MOTORIZED 3-WHEELED VEHICLE, Class II, 21 CFR 890.3800

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 HEARTWAY Lightweight Power Mobility Scooter, S33 is an indoor / outdoor electric scooter that is battery operated. It has a base with three-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

Performance Testing:

EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: WU'S 3-WHEELED NEO SCOOTER, WT-T3D (K032488)

DI

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## HEARTWAY MEDICAL PRODUCTS CO.

NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK. TAICHUNG TAIWAN I :886-4-23580357 (Sales) - 23583232 (Rep) FAX :[phone]

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#### Summary for substantial equivalence comparison:

The intended use between the two devices is the same. Mainframes materials of the two devices are fixed, and all meet the strength and fatigue tests and they use the same material aspects. The weight capabilities, maximum speed, suspension of cross brace, footplates, and armrest type are all the same. The back upholstery material is also the same fabric and passed the resistance ignition test. - Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.

The main difference for the two devices is overall appearance. Besides, the incline degree is 8° for the predicate device and the new device can drive under 10° slope. We provide the relevant specifications for ground clearance and curb climbing ability in the Owner's Manual. Thus, the user is not allowed to operate the device on the incline angle higher than the specified angle. The safety levels of the two devices are the same when operating the devices on the different inclines. They are substantially equivalent.

The cruising range per charge for the two devices is difference. This means the new device is 18 miles cruising range, the predicate device is 10 miles. Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Heartway Medical Products Co., Ltd. % Chinese-European Industrian Research Society Dr. Ke-Min Jen No. 58, Fu-Chium Street Hsin-Chu City, Taiwan 408 Republic of China

APR 1 9 2007

Re: K071007

Trade/Device Name: Heartway Lightweight Power Mobility Scooter, S33 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: April 4, 2007 Received: April 9, 2007

Dear Dr. Jen:

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. Iisting 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 -- Dr. Ke-Min Jen

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,

for Rob

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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# Indications for Use

510 (K) Number ( If Known ): K

Device Name: HEARTWAY Lightweight Power Mobility Scooter, S33

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 NEEDE

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign- IT) Division of Get eral. Restorative, and Neurological Devices

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