(55 days)
The Bewell SC 20 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 Bewell SC 20 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 Bewell SC 20 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 35.2 km (22 miles) with 36AH which maximum speed upto 9 km/hr (5.6 mph).
The available text does not describe acceptance criteria for a medical device's performance, nor does it detail a study proving such performance. Instead, the document is a 510(k) summary for a mobility scooter, the Bewell SC 20. The summary primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to relevant safety standards.
Therefore, I cannot provide the requested information. The document does not contain:
- A table of acceptance criteria and reported device performance related to a medical outcome.
- Information on sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth in a clinical or performance study.
- Details about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI assistance.
- Information about a standalone algorithm-only performance study.
- The type of ground truth used in a clinical study.
- Sample size for a training set or how ground truth for a training set was established.
What the document does include regarding performance is:
- Non-Clinical testing: The Bewell SC 20 scooter was tested to various wheelchair standards, including:
- ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
- ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods
- ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters
- CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics -- limits and methods of measurement
- IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD)
- IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test
- California Bureau of Home Furnishings 116 Flammability Standards
The document states that "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." However, it does not specify the numerical acceptance criteria for each of these tests or the detailed results beyond a general statement of compliance.
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7, 510(k) summary
JAN 2 6 2005
510(k) Summary
CHC / Cycling and Health Tech Industry R&D Center
Bewell SC 20 scooter
Proprietary and Manufacturer information:
Cycling and Health Tech Industry R&D Center/CHC No. 17, 37th Rd., Taichung Industry Park, Taichung, Taiwan Contact person: Chang Wan-Lan Director of Testing Department Phone: 886-4-23501100 Facsimile: 886-4-23504590 e-mail: cwl(@tbnet.org.tw Date prepared: November 10, 2004
Device
Trade name: Bewell SC 20 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
Manufacture name: TUNG DENG ENTERPRISE CO., LTD. Name: Be-Mobile 4-Wheeled Electric Scooter, DK S500 k number: K033239 Date cleared: 12/18/2003
Intend use of device
Bewell SC 20 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
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Device description:
The Bewell SC 20 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 Bewell SC 20 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 35.2 km (22 miles) with 36AH which maximum speed upto 9 km/hr (5.6 mph).
Substantial equivalence:
The Bewell SC 20 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 Bewell SC 20 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 they raise any new questions pertaining to safety or effectiveness. Therefore, CHC believes that the Bewell SC20 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
Non-Clinical testing
Bewell SC 20 scooter has been tested to wheelchair standards. They include:
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- (1). ANSI/RESNA WC/Vo1.1 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
Image /page/2/Picture/7 description: The image shows a black and white abstract pattern. The pattern is mostly black on the right side and fades to white on the left side. The black area has a rough, textured appearance, while the white area is smooth and uniform.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
JAN 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chang Wan Lan Cycling and Health Tech. Industry R& D Center Testing Department No.17 RD Taichung, China (Taiwan) 407
Re: K043326
Trade/Device Name: Bewell SC 20 Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: December 20, 2004 Received: January 4, 2005
Dear: Mr. Chang 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 (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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Mr. Chan 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/cdrl/industry/support/index.html.
Sincerely yours,
Mark A. Milkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): ______________________
Device Name: Bewell SC 20
Indications for Use:
The Bewell SC 20 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 |
|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERPAGE OF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of 1 |
for Mark A. Milliken
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number: K043326
(Posted November 13, 2003)
§ 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).