FORU, MODEL EQ30

K072630 · Kwang Yang Motor Co., Ltd. · INI · Oct 3, 2007 · Physical Medicine

Device Facts

• Record ID: K072630
• Device Name: FORU, MODEL EQ30
• Applicant: Kwang Yang Motor Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Oct 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The ForU EQ30 scooter is motor driven, indoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Device Story

ForU EQ30 is a battery-operated, motorized three-wheeled scooter for indoor/outdoor transportation. Operated by the user via a tiller handle and thumb-actuated potentiometer throttle control lever; provides forward and reverse motion. Features include foldable armrests, foldable tiller, and reclinable backrest. Safety systems include intelligent regenerative electromagnetic braking, hand brake, and anti-tip wheels. Device provides mobility for disabled or elderly individuals unable to walk long distances. Output is physical transport of the user. No complex software or AI algorithms involved.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on descriptive comparisons of technical specifications and intended use.

Technological Characteristics

Battery-operated (12V x 31AH x 2) motorized three-wheeled vehicle. DC24V 350W motor. Sealed transaxle direct drive. Thumb-operated potentiometer throttle. Intelligent regenerative electromagnetic brake and hand brake. Steel tube and engineering plastic construction. 10" pneumatic tires. Foldable armrests and tiller. No software-based algorithms.

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring indoor 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

• AVANTICARE SA4022 (K051538)

Submission Summary (Full Text)

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K072630

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## KWANG YANG MOTOR CO., LTD.

No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan TEL: [phone] FAX: [phone]

## 510(k) Summary

### Device

OCT 3 2007

Trade name: ForU EQ30 scooter Common name: Electrical scooter

Classification name: Motorized three-wheeled vehicle

Medical specialty (Panel): Physical Medicine Device

Regulation number: 890.3800

Product Code: 89INI

Classification: Class II

### Predicate devices

### AVANTICARE SA4022(K051538)/ LERADO CHINA LIMITED

### Intend use of device

ForU EQ30 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

### Device description:

The ForU EQ30 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

### Substantial equivalence:

The ForU EQ30 scooter is substantially equivalent to the AVANTICARE SA4022 (K051538) manufactured by LERADO CHINA LIMITED.

There are minor differences in performance specifications of the scooters, 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, KWANG YANG MOTOR CO., LTD. believes that the ForU EQ30 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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# KWANG YANG MOTOR CO., LTD.
No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan

5, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
TEL: [phone] FAX: [phone]

The substantial equivalence comparison of the ForU EQ30 and SA4022

| | SA4022(K051538) | ForU EQ30 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Intended use | Three scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide<br>mobility to disabled or elderly persons limited to a seated position. | |
| Maximum loading | 135 kg (300 lbs) | 150 kg (330 lbs) |
| Overall height | 980 mm (38.5") | 1250 mm (49.2") |
| Overall length | 1160 mm (45.7") | 1240 mm (48.8") |
| Overall width | 540 mm (21.3") | 560 mm (22") |
| Seat overall height | 520 mm (20.5") | 756 mm (29.8") |
| Seat overall width | 457 mm (18") | 455 mm (17.9") |
| Seat overall depth | 406 mm (16") | 400 mm (15.7") |
| Seat overall weight | 15 kg (33 lbs) | 15.2 kg(33.4 lbs) |
| Motor output | 350W x DC24V × 5100 RPM, 1PC | 350W x DC24V × 1PC |
| Controller | Dynamic DS72K01 | KYSA 70 |
| Differential<br>mechanism | Differential rate: 19.7 : 1 | |
| Rear wheel drive | | Sealed transaxle direct drive |
| Operation mode | | Thumb operated potentiometer throttle control lever |
| Battery | Lead-Acid 12V × 36AH × 2PCs | Lead-Acid 12V x 31 AH × 2PCs |
| Battery level<br>indicator | | Yes |
| | The substantial equivalence comparison of the ForU EQ30 and SA4022 | |
| (Continuous) | SA4022(K051538) | ForU EQ30 |
| Charger | HP 24V 3/5AMP (Automatic Type) off-board | HP 24V, 5 AMP (Automatic Type) on-board |
| Front wheel | 10" x 2" foam filled tire × 2 PCs<br>Rim: aluminum alloy | 10" x 5" pneumatic tire × 2 PCs |
| Bumpers | Front/Rear: It's constructed by engineering plastics | Front: It's constructed by steel tube<br>Rear: It's constructed by engineering plastics |
| Armrest | | Yes, Foldable |
| Tiller foldable | | Yes |
| Backrest recline | | Yes |
| Recline angle<br>indicator | | No |
| Headrest | | No |
| Height adjustable | | No |
| Rear wheel | 10" x 2" foam filled tire × 2 PCs<br>Rim: aluminum alloy | 10" x 5" pneumatic tire × 2 PCs |
| Break system | | Intelligent regenerative electromagnetic brake and hand brake |
| Braking distance | 1.88 m (74") | Forward: 1.24 m (48.8") at max speed |
| Net weight with<br>battery | 81 kg (178 lbs) | 84.4 kg(185.7 lbs) |
| Slope grade ability | 12 degree | 10 degree |
| Continuous | The substantial equivalence comparison of the ForU EQ30 and SA4022 | |
| | SA4022(K051538) | ForU EQ30 |
| Per-charge distance | 35 km (22 miles) | Up to 37 km (23.1 miles) |
| Maximum speed | 8.5 km/h (5.3 mph) | Up to 8 km/hr (4.7 mph), variable |
| Speed mode | | Single mode, Variable |
| Turning radius | 1450 mm (57") | 1565 mm (61.6") |
| Maximum curb<br>height | 90 mm (3.5") | 80 mm (3.14") |
| Suspension | Front: No, | Rear: Yes |
| Head/Tail lights<br>Signal light | Head/tail lights and<br>Signal light | signal lights of the EQ30 and SA4022 scooters have the same functions, but only the |
| | styles are different. | |
| Warning light | | Yes |
| Horn | | Yes |
| Anti-tip wheels | | Yes |

7-2

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KWANG YANG YANG MOTOR CO., LTD.
6. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
F

TEL: [phone] FAX: [phone]

MIRASYS, 4, ANMIN ST., SAN MIN DIST., KAOHSIUNG, TAIWAN

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Image /page/3/Picture/0 description: The image shows a black and white symbol that resembles an eye. The symbol is enclosed in an oval shape. Inside the oval, there is a crescent shape above a horizontal line.

# KWANG YANG MOTOR CO., LTD.
No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
TEL: [phone] FAX: [phone]

5, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
TEL: [phone] FAX: [phone]

The substantial equivalence comparison of the ForU EQ30 and SA4022

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes extending diagonally upwards and to the right. The eagle is positioned above a wavy line, which may represent water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

0CT 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KWANG YANG MOTOR CO., LTD. % Ms. Juannata Chang No. 35, Wan Hsing Street San Min Dist., 803 Kaohsiung, Taiwan

Re: K072630 Trade/Device Name: ForU EQ30 Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 10, 2007 Received: September 18, 2007

Dear Ms. Chang:

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 -- Ms. Juannata Chang

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,

Neil R. B. Oyler

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: ForU EQ30

Indications for Use:

The ForU EQ30 scooter is motor driven, indoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C) AND/OR (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

Nil R.P. Oglin for mxm

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

510(k) Number K072630

(Posted November 13, 2003)