(129 days)
Not Found
No
The device description and performance studies focus on basic mechanical and electrical components and standard wheelchair testing, with no mention of AI/ML terms or functionalities.
No
The device is a mobility aid (scooter) intended for transportation of disabled or elderly persons, not for the treatment or cure of a disease or condition. While it improves mobility, it does not fit the definition of a therapeutic device.
No
The device description clearly states its intended use is for "mobility to disabled or elderly persons limited to a seated position." There is no mention of diagnosing conditions or diseases.
No
The device description clearly outlines numerous hardware components including a frame, motor, batteries, braking system, and more, indicating it is a physical device, not software-only.
Based on the provided information, the HOLI I scooter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mobility to disabled or elderly persons. This is a physical function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description details a motor-driven vehicle for transportation. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions based on sample analysis
- Reagents, calibrators, or controls
The HOLI I scooter is clearly a mobility aid, falling under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The HOLI I 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.
Product codes (comma separated list FDA assigned to the subject device)
89INI
Device Description
The HOLI I 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.
The HOLI I scooter is with a 130 kg (286 lbs) weight capacity.
The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat.
It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The scooter is powered by two 12 volt lead-acid DC batteries with 27 km (16.9 miles) with 32/36AH which maximum speed upto 9.5 km/hr (5.6 mph).
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
disabled or elderly persons
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)
HOLI I scooter has been tested to wheelchair standards. They include:
- (1). ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
- (2). ANSI/RESNA WC/Vol.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods
- (3). ANSI/RESNA WC/Vol.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.
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
Manufacture name: TUNG DENG ENTERPRISE CO., LTD.
KOSO 50 7 JUL 7 - 2005
510(k) Summary
Smartech Co., LTD.
HOLI I scooter
- 510(k) summary
Sponsor's information:
Phone: +886-4-23501100 Facsimile: +886-4-23504590 e-mail: cwl@tbnet.org.tw
Smartech Co., LTD.
Phone: +886-4-26814881 Facsimile: +886-4-26815211
Device
Date prepared: February 25, 2005
Proprietary and Manufacturer information:
Contact person: Irene Kuo, President
e-mail: lungi001@ms5.hinet.net
Trade name: HOLI I scooter
Regulation number: 890.3800
Product Code: 89INI Classification: Class II
Predicate devices
Common name: Electrical scooter
Cycling and Health Tech Industry R&D Center
No. 17, 37th Rd., Taichung Industry Park, Taichung, Taiwan
No. 3, Kung 10th Rd., Tachia Town, Taichung Hsien, Taiwan
Contact person: Dr. Chang Wan-Lan, Director of Testing Department
Name: Be-Mobile 4-Wheeled Electric Scooter, DK S500
Classification name: Motorized three-wheeled vehicle Medical specialty (Panel): Physical Medicine Device
7-1
1
KOSOSO7
Intend use of device
HOLI I scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The HOLI I 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.
The HOLI I scooter is with a 130 kg (286 lbs) weight capacity.
The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat.
It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The scooter is powered by two 12 volt lead-acid DC batteries with 27 km (16.9 miles) with 32/36AH which maximum speed upto 9.5 km/hr (5.6 mph).
Substantial equivalence:
The HOLI I scooter is substantially equivalent to the Be-Mobile 4-Wheeled Electric Scooter, DK S500 (K033239) manufactured by TUNG DENG ENTERPRISE CO., LTD..
Analysis of comparison of design, function and feature of HOLI I scooter to TUNG DENG DK S500 (K033239), together with the results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended.
While 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
2
they raise any new questions pertaining to safety or effectiveness. Therefore, Smartech believes that the HOLI I scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
Non-Clinical testing
HOLI I scooter has been tested to wheelchair standards. They include:
- (1). ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
- (2). ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods
- (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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
JUL 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chang Wan-Lan Cycling and Health Tech. Industry R & D Center Number 17, 37th Road Taichung Industry Park Taichung, China (Taiwan) 40768
Re: K050507
Trade/Device Name: HOLI I Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 9, 2005 Received: June 9, 2005
Dear Mr. Wan-Lan:
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 (2) __ 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.
4
Page 2 – Mr. Chang Wan-Lan
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stupt Rlurdu
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
- Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HOLI I
Indications for Use:
The HOLI I 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 _X Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page I of 1
Stupt Alurde
(Division' Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_ (050507
(Posted November 13, 2003)