(187 days)
Mobility assistive device for indoor use and outdoor usc on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.
The Elite Scooter is a mobility assistive device for indoor use and outdoor use on mild terrain. The Elite Scooter is an ultra-light, compact, portable vehicle. It is designed for the use of active individuals that are able to walk short distances, but need assistance. The user must have sufficient arms and legs strength to get on and off the Elite on his/her own and to steer without effort under all driving conditions. The maximum allowed weight of the user is 250 lbs. The Elite features the patented Wheel Drive system that incorporates the motor in the front wheel for additional ease of steering. The innovation is restricted to the modification of the design and construction of the hub type magnet brush pancake motor and drive unit. The Elite has the following main components: The Foldable rear frame and the Steering column made from steel tubular welded parts with an oven baked powder coated paint finish. A single drive wheel and two free turning rear wheels. All three wheels are solid. The front wheel size is 10"x2", the rear wheel size is 8"x2". The seat is made from two Polypropylene injected molded vinyl covered foam. The backrest folds down and latches for transportation. The seat is adapted and fitted to the foldable rear-frame. The front wheel drive with a DC permanent magnet brush pancake motor. Because the reduction gear is a spur gear and not worm gear it is a very efficient system. The hub assembly, comprises the drive wheel, pancake shaped PM dc motor, reduction gearbox and an electro-magnetic brake. It has a slick structure, compact dimensions, high efficiency and low noise. It has no moving parts; is fixed to the front fork of the Elite. An electro-magnetic brake connected to its rear shaft. The brake is released electrically by the controller during motor operation, and applied after the motor decelerates and comes to a stop. A mechanical spring automatically applies the brake in case of an electrical failure. The control is a forward/reverse wigwag type that can be operated by both left and right hand. A speed adjustment knob limits the maximum speed. There is a Power On/Off key switch on the control panel, a battery gauge and a LED for low battery and fault condition indication. The brake release toggle is on the control cover. The Controller from Penny and Giles Drives Technologies Ltd. (UK), conforms to all applicable international standards. The 12V battery packs are available in two sizes: the Mini-size pack contains 7.2Ah capacity batteries and the Jumbo size pack -- 12Ah capacity. There is a short-circuit protection fuse in the Battery Pack. The 100-240 VAC charger charges the batteries either directly (off board) or via a socket on the front column with an inhibit feature that does not allow the scooter to be driven when the batteries are being charged. Carrying Basket placed below the seat.
The provided text is a 510(k) summary for "The Elite - ultra-light, compact portable scooter". It describes the device, its components, and its intended use. However, this document does not contain information regarding acceptance criteria, study details (sample size, data provenance, ground truth, experts, adjudication), or MRMC/standalone study results.
Therefore, I cannot provide the requested information based on the provided input. The prompt specifically asks to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" based on the input. Since this information is not present in the provided text, I must state that.
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510k Summary
175 2006
The Elite Scooter is a mobility assistive device for indoor use and outdoor use on mild The Litte Scouler is a moonly about which on roads and freeways used by cars. The Elite Scooter is an ultra-light, compact, portable vehicle.
It is designed for the use of active individuals that are able to walk short distances, but n 15 designed for the ass of assisting. The user must have sufficient arms and legs street than minor moonly in and off the Elite on his/her own and to steer without effort under all driving conditions. The maximum allowed weight of the user is 250 lbs.
The Elite features the patented Wheel Drive system that incorporates the motor in the front wheel for additional ease of steering
The innovation is restricted to the modification of the design and construction of the hub type magnet brush pancake motor and drive unit.
The Elite has the following main components:
- The Foldable rear frame and the Steering column made from steel tubular welded . parts with an oven baked powder coated paint finish.
- A single drive wheel and two free turning rear wheels. All three wheels are . A single direc wheel size is 10"x2", the rear wheel size is 8"x2"
- The seat is made from two Polypropylene injected molded vinyl covered foam. . The backrest folds down and latches for transportation. The seat is adapted and fitted to the foldable rear-frame.
- The front wheel drive with a DC permanent magnet brush pancake motor. Because ● the reduction gear is a spur gear and not worm gear it is a very efficient system.
- The hub assembly, comprises the drive wheel, pancake shaped PM dc motor, ◆ reduction gearbox and an electro-magnetic brake. It has a slick structure, compact roubtion gears of the refficiency and low noise. It has no moving parts; is fixed to the front fork of the Elite.
- An electro-magnetic brake connected to its rear shaft. The brake is released . An elocally by the controller during motor operation, and applied after the motor decelerates and comes to a stop. A mechanical spring automatically applies the brake in case of an clectrical failure.
- The control is a forward/reverse wigwag type that can be operated by both left and right hand. A speed adjustment knob limits the maximum speed. There is a Power On/Off key switch on the control panel, a battery gauge and a LED for low battery and fault condition indication. The brake release toggle is on the control cover.
- The Controller from Penny and Giles Drives Technologies Ltd. (UK), conforms to . all applicable international standards.
- The 12V battery packs are available in two sizes: the Mini-size pack contains . 7.2Ah capacity batteries and the Jumbo size pack -- 12Ah capacity. There is a short-circuit protection fuse in the Battery Pack.
- The 100-240 VAC charger charges the batteries either directly (off board) or via a . socket on the front column with an inhibit feature that does not allow the scooter to be driven when the batteries are being charged.
- Carrying Basket placed below the seat
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (USA). The seal features a stylized eagle with three stripes above its head, representing the department's mission to protect the health of all Americans and provide essential human services. The department's name is written in a circular fashion around the eagle.
Public Health Service
FEB 1 5 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alex Gonorovsky Manager, Regulatory Affairs Tzora Active Systems Ltd. Kibbutz Tzora, 99803 Israel
Re: K052204
Trade/Device Name: The Elite - ultra-light, compact portable scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: December 14, 2005 Received: January 10, 2006
Dear Mr. Gonorovsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regary the Medical Device Amendments, or to connine.co proc to May 20, 1978, as occordance with the provisions of the Federal Food, Drug, devices mat have been recussioned in quire approval of a premarket approval application (PMA). and Costience Act (Tec) that as not request if the general controls provisions of the Act. The r ou may, therefore, mainer of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device ts classified (soc are ro) mis . Existing major regulations affecting your device can may be subject to saeli additions, 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 I lease of advised that i Drivisation that your device complies with other requirements of the Act that I DA has made a determanlations administered by other Federal agencies. You must of any I cach statutes and regulations and admited to: registration and listing (21 Comply with an the Act 31equirements, and manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic forth in the quarty Bybishio (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Gonorovsky
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin mankeling your antial equivalence of your device to a legally premarket notheation: "The FDA mianing of basion 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 If you desire specific advice for your ac 10-10-20. Also, please note the regulation entitled, Colliact the Office of Compliance at (210) = 16 = 16 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = Misoranung by reference to premains not the Act from the Division of Small other general informational 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/dsma/dsmamain.html
Sincerely yours,
Sincerely, y'all,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/2 description: The image shows the text "510(k) Number: K052208" in a serif font. There is a number 4 in the top right corner of the image. The number K052208 is likely a reference to a medical device submission to the FDA.
Device Name: The Elite - ultra-light, compact portable scooter
Indication for Use:
Mobility assistive device for indoor use and outdoor usc on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.
Prescription Use (Part 21 CFR 801 Subpart D AND/OR
Over-The-Counter Use_ (21 CF 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hufort Lenato
(Division Sign Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052204
§ 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).