(18 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of a standard mobility scooter with manual controls. There is no mention of AI, ML, image processing, or data-driven decision-making.
No
The device is described as an electric scooter for mobility, not for treating or alleviating a medical condition. Its function is to provide movement to individuals, which is a supportive role, not a therapeutic one.
No
The device is described as an "indoor / outdoor Electrical Scooter" intended "to provide mobility to persons restricted to a seated position." It is a mobility aid, not a device used to identify or determine the nature of a disease or condition.
No
The device description clearly states it is an "indoor / outdoor Electrical Scooter" with physical components like a base, wheels, seat, hand controls, and a battery charger, indicating it is a hardware device with electrical components, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a seated position. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details an electric scooter, a mobility aid. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples
- Detection or measurement of substances in the body
- Diagnosis, monitoring, or screening of diseases or conditions through laboratory tests
The device is a mobility aid, falling under a different category of medical devices.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The LERADOTECH Scooter, SB is an indoor / outdoor Electrical Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the The device can be disassembled for transport and is provided with steering column. an onboard battery charger.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Electrical Scooters, controller, and their chargers requirements and test methods)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
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.(b)
Classification. Class II (performance standards).
0
APR 1 3 2007
Image /page/0/Picture/1 description: The image shows a logo with the word "LERADO" in large, bold letters. A stylized image of a tree is placed between the letters "R" and "D". Below the word "LERADO" is the text "LERADO GROUP" in a smaller font. Below that is some text in a different language.
LERADO CHINA LIMITED
No. 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Tahwan, ROC. Tel: 886-5-2475629 Fax: 886-5-2379672 E-mail:edwardlaglerado.com tw http:// www.lerado.com
510(k) SUMMARY " દ્ધ
Submitter's Name: LERADO CHINA LIMITED
Dong Sheng Road North Zhong Shan, CHINA
Date summary prepared:
Device Name:
March 17, 2007
Proprietary Name: Common or Usual Name: Classification Name:
Electrical 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.
LERADOTECH Scooter, SB
Description of the device:
The LERADOTECH Scooter, SB is an indoor / outdoor Electrical Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the The device can be disassembled for transport and is provided with steering column. 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 Electrical Scooters, controller, and their chargers requirements and test methods)
Legally marketed device for substantial equivalence comparison: COMFORT Scooter LY-EW415 (K063032)
1
Image /page/1/Picture/0 description: The image shows the logo for LERADO Group. The logo is in black and white and features the company name in a stylized font. Above the company name is a triangular shape that resembles a mountain. Below the company name are some Chinese characters.
LERADO CHINA LIMITED No. 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Tel: 886-3-2475629 · Fax: 886-5-2379672 E-mail edwardl@lerado.com tw http:// www.lerado.com
Summary for substantial equivalence comparison:
The new device SB and the predicate device LY-EW415 are the same intended uses and warranty period, and the electronic systems between the two devices are all passed by the UL certificated. Except the recharger of the electronic systems, the two devices are the same suppliers. Especially, the two devices use the same controller and switching power supplier. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured.
The major difference existing for the two devices are tires size, weight limit, weight capabilities, and the dimensions for the new device are more agile and smaller than those of the predicate device. Thus the new device can drive smaller turning radius and safe climbing angle. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
The maximum speed is 6.0 mph for the new device and 5.0 mph for the predicate device that are also under the 6 miles maximum speed limited. The speeds can be continuous adjusted by the throttle tiller. The operators can set the adequate speed according to their feeling and need, and the maximum speed differences do not mean any performance differences. They are substantially equivalent.
The cruising range of the new device is 36 km and 75 km for the predicate device. This is mainly due to the fact that the batteries for the new device are smaller. Certainly the real range depends on the practice environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.
Based on the above the information and the analysis, we know that the subject device and the predicate devices have the same intended use, the same technological aspects and only minor dimensions or data differences exist. Thus the subject device and the predicate device are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lerado China Limited % Republic of China Chinese-European Industrial Research Society Dr. Ke-Min Jen Official Correspondent No. 58, Fu-Chiun Street Hsin-Chu City China (Taiwan) 30067
APR 1 3 2007
Re: K070817
Trade/Device Name: LERADOTECH Scotter, SB Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: March 17, 2007 Received: March 26, 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
3
Page 2 – Dr. Ke-Min Jen
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 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 (240) 276-0120 . 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510 (K) Number ( If Known ): __ K
Device Name: LERADOTECH SCOOTER, SB
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 16070817
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)
Page 1 of 1