LERADOTECH, MODEL SC

K070802 · Lerado China Limited · INI · Apr 13, 2007 · Physical Medicine

Device Facts

• Record ID: K070802
• Device Name: LERADOTECH, MODEL SC
• Applicant: Lerado China Limited
• Product Code: INI · Physical Medicine
• Decision Date: Apr 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The LERADOTECH SC scooter 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

Battery-operated, motorized three-wheeled scooter; provides indoor/outdoor transportation for disabled or elderly users. User operates via tiller handle and thumb-actuated potentiometer throttle control lever to manage speed and direction (forward/reverse). Features include foldable armrests, backrest recline, and battery level indicator. Braking system utilizes intelligent regenerative electromagnetic brake and manual hand brake. Device intended for personal use by the mobility-impaired to improve independence and mobility.

Clinical Evidence

Bench testing only. Device tested for static stability (ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999), speed/acceleration/deceleration (ANSI/RESNA WC/Vol.1 section 6-1998 / ISO7176-6-2001), electromagnetic compatibility (ANSI/RESNA WC/Vol.2 section 21-1998 / ISO7176-21-2003), RF disturbance (CISPR 11-1990), ESD immunity (IEC 61000-4-2-1995), radiated RF immunity (IEC 61000-4-3-1995), and flammability (California Bureau of Home Furnishings 116).

Technological Characteristics

Battery-operated (12V x 75AH x 2PCS) motorized three-wheeled scooter. Steel tube and engineering plastic construction. Sealed transaxle direct drive. Intelligent regenerative electromagnetic brake system with auxiliary hand brake. 13" x 5" pneumatic tires. Dynamic DS16K01 controller. Complies with ANSI/RESNA and ISO 7176 series standards for stability, performance, and EMC.

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring indoor/outdoor 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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K070802

Image /page/0/Picture/1 description: The image shows the logo for Lerado Group. The logo is black and white and features the word "LERADO" in large, bold letters. The "A" in "LERADO" is replaced by a triangle shape. Below the word "LERADO" is the word "GROUP" in smaller letters.

ERADO CHINA LIM No.22, Kuang Fu Rd., Chia Tai Industrial Park, Tai Pao City, Chia Yi Hsien, Taiwan TEL: [phone] FAX: [phone] website:http://www.lerado.com/

## 510(k) Summary

#### Device

APR 1 3 2007

Trade name: LERADOTECH SC 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

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

Device description:

The LERADOTECH SC 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 LERADOTECH SC 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, LERADO CHINA LIMITED believes that the LERADOTECH SC scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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| (Continuous) | Table 6-1 The substantial equivalence comparison of the LERADOTECH SC and SA4022<br>SA4022(K051538) | LERADOTECH SC |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Operation mode | Thumb operated potentiometer throttle control lever | |
| Battery | Lead-Acid 12V × 36AH × 2PCS | Lead-Acid 12V x 75AH × 2PCS |
| Battery level indicator | | Yes |
| Charger | HP 24V 3/5AMP (Automatic Type) off-board | HP 24V, 5 AMP (Automatic Type) off-board |
| Front wheel | 10" x 2" foam filled tire × 2 PCs<br>Rim: aluminum alloy | 13" 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<br>Recline angle indicator | | Yes |
| Headrest | | No |
| Height adjustable | | No |
| Rear wheel | 10" x 2" foam filled tire × 2 PCs<br>Rim: aluminum alloy | 13" x 5" pneumatic tire × 2 PCS |
| Break system | Intelligent regenerative electromagnetic brake | Intelligent regenerative electromagnetic brake and<br>hand brake |
| Table 6-1 The substantial equivalence comparison of the LERADOTECH SC and SA4022 | | |
| | SA4022(K051538) | LERADOTECH SC |
| 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) | 205 kg (450 lbs) |
| Overall height | 980 mm (38.5") | 1260 mm (50") |
| Overall length | 1160 mm (45.7") | 1370 mm (54") |
| Overall width | 540 mm (21.3") | 730 mm (29") |
| Seat overall height | 520 mm (20.5") | |
| Seat overall width | 457 mm (18") | |
| Seat overall depth | 406 mm (16") | |
| Seat overall weight | 15 kg (33 lbs) | |
| Motor output | 350W x DC24V × 5100 RPM, 1PC | 950W x DC24V × 1PC |
| Controller | Dynamic DS72K01 | Dynamic DS16K01 |
| Differential<br>mechanism | Differential rate: 19.7: 1 | |
| Rear wheel drive | | Sealed transaxle direct drive |

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comparison of the LERADOTECH SC and SA4022 Table 6-1 The substantial equivalence

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### 3.2 Performance standards

LERADOTECH SC scooter has been tested the applicable performance requirements specified in:

- (1). ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
- (2). ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001 Determination of max speed, acceleration and deceleration of electric wheelchair
- (3). ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters
- (4). CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics - limits and methods of measurement
- (5). IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD)
- (6). IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test
- (7). California Bureau of Home Furnishings 116 Flammability Standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lerado China Limited % Ms. Junnata Chang 14F-2, No. 1, Zhuangjing Road, Lane 25 Bangiao, Taipei County China (Taiwan)

Re: K070802

Trade/Device Name: LERADOTECH SC scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: March 15, 2007 Received: March 23, 2007

APR 1 3 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, 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. 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

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Page 2 - Ms. Junnata 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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

For
Mark N. Melkerson
Director

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: LERADOTECH SC

Indications for Use:

The LERADOTECH SC scooter 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.

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

signature

Division Sign Division of Gey .. and Neurologi ... Dec

510(k) Number

(Posted November 13, 2003)