HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT

K070489 · Heartway Medical Products Co., Ltd. · ITI · Mar 14, 2007 · Physical Medicine

Device Facts

• Record ID: K070489
• Device Name: HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT
• Applicant: Heartway Medical Products Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Mar 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The HEARTWAY Power Tilt Seating System Power Chair (P16RT) is a battery-operated, four-wheeled indoor/outdoor powered wheelchair. It features a seat, armrests, and a front basket. The rider operates the device using hand controls located on the steering column. The chair includes a power tilt seating system. The device is designed to be disassembled for transport and includes an onboard battery charger. It is intended for use by individuals with mobility restrictions to provide independent movement.

Clinical Evidence

No clinical data. Performance testing was limited to bench testing, specifically EMC and electrical safety testing per ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-3-2:1995, and IEC61000-3-3:1995.

Technological Characteristics

Battery-operated powered wheelchair with power tilt seating. Materials meet strength and fatigue standards. Electronic systems (controller, batteries, switches) are UL certified. Connectivity is standalone. Testing performed per ANSI/RESNA WC/Vol.2-1998 and IEC standards for electrically powered wheelchairs.

Indications for Use

Indicated for persons restricted to a seated position requiring 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

• FORYOU POWERED WHEELCHAIR, FC-100 (K061693)

Submission Summary (Full Text)

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K070489.

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HEARTWAY MEDICAL PRODUC

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MAR 1 4 2007

February 13, 2007

## 510(k) SUMMARY "

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 Power Tilt Seating System Power Chair, P16RT POWERED WHEELCHAIR POWERED WHEELCHAIR, Class II, 21 CFR 890.3860

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 Power Tilt Seating System Power Chair, P16RT is an indoor / outdoor electric scooter that is battery operated. It has a base with four-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: FORYOU POWERED WHEELCHAIR, FC-100 (K061693)

DI

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HEARTWAY MEDICAL PRODUCTS CO.,L BOAD 25 TAICHUNG INDUSTRIAL PARK. TAICHUNG TAIM

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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 all meet the strength and fatigue tests and they use the same material aspects. The suspension of cross brace, footplates, armrest type, and the warranty 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 major differences existing are the overall dimensions, maximum speed, cruising range, the incline degrees, and special designed for the power tilt seating system are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

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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. % ROC Chinese-European Industrial Research Society Dr. Ke-Min Jen Official Correspondent No. 58, Fu-Chiun Street Hsin-Chu City, Taiwan Republic of China

MAR 1 4 2007

Re: K070489

Trade/Device Name: Heartway Power Tilt Seating System Power Chair, P16RT Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 5, 2007 Received: February 14, 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, 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

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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 Pedro Nunez

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 Power Tilt Seating System Power Chair, P16RT

Indications for Use:

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

Prescription Use

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use √

(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 | |
| 510(k) Number | K070489 |

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