(39 days)
Not Found
No
The description focuses on mechanical and electrical components and does not mention AI or ML.
No.
The device is described as a mobility assistive device for physically challenged people and the elderly, not for treating a disease or condition. Its purpose is to assist with mobility, which is a supportive function rather than a therapeutic one.
No
The device is described as a "mobility assistive device" for "physically challenged people and elderly people." Its intended use is for mobility assistance, not for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including a motor, batteries, chassis, body covers, transaxle, seat, controller, and battery charger.
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 an "indoor and outdoor mobility assistive device" for "physically challenged people and elderly people." This describes a device used to aid physical movement, not to diagnose a condition by examining samples from the body.
- Device Description: The description details the mechanical and electrical components of an electric scooter. 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 IVDs, such as:
- Analyzing blood, urine, tissue, or other bodily fluids/samples.
- Detecting or measuring specific substances (analytes) in these samples.
- Providing diagnostic information about a disease or condition.
The device is a mobility aid, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Used as an indoor and outdoor mobility assistive device. Never used as a transportation tool on highways and freeways.
Product codes (comma separated list FDA assigned to the subject device)
89INI
Device Description
The Jupiter 50 electric scooter is a mobility assistive device for physically challenged people and elderly people. It is motorized by a 24V DC motor. Two or four 12 volt batteries supply electrical power. Jupiter 50 consists of seven major components: chassis, body covers, transaxle, seat, controller, batteries, and battery charger. The chassis is divided into three parts: the tiller, the front and the rear chassis. The front and rear chassis are jointed by two pin shafts and secured by two U-shaped pins. They can be assembled or dismantled in less than a minute without using any tools. The tiller is articulated by its upper and lower parts to provide the maximum flexibility. There is a wind shield attached to the handle bar. A unique function of this is to provide a temporary table for holding coffee cup, books, and et. A Jupiter's user can write or work with convenience. The scooter fairing are made of high-strength plastic - PBS. They cover the chassis and tiller. Their surfaces are painted by baked paint with high finishing. A headlight is installed in the front fairing and two turning lights are in the rear. Those lights enhance drive safety greatly by providing not only signals to other vehicle drivers and pedestrians, but also by lighting road surface and obstacles to avoid collision or other accidents. A sealed drive train is used in Jupiter scooter. No moving part is exposed. A 24-volt permanent magnetic direct current motor delivers up to 400 Watts power to the system. Motor speed is reduced through gear pairs to its desired wheel shaft speed. The inbedded differential gives the right and the left wheel different speed when the scooter makes turn. All moving parts and bearings inside the gear box are well lubricated by low-viscosity grease. The design of every part is carefully calculated and tested. Such design reduces requirement in maintenance and greatly increases its reliability and ensure a long service life. An electric dynamic brake is attached to the motor shaft. The braking function is applied when no electric current passes its inductive coils and vanishes when speed control throttle is activated. The Jupiter can stay firmly on a slope of 9 degrees without slipping. This is a very important safety feature every scooter must have in case of sudden electric circuit failure. There is a clutch handle to release the brake locking in order to free wheeling when needed. Two 30 Ah 12-Volt sealed gel-cell batteries are secured at the top of chassis. A full charge can make a 25 miles travel. The Jupiter 50 also can accommodate four batteries. It increases travel distance to more than 40 miles and lowers the center of gravity of the man-vehicle system. therefore it improves its static and dynamic stability substantially. The battery charger is built-in with a extension cord. A user can charge the batteries conveniently wherever a power outlet can be found. It takes 6 to 8 hours to charge an almost discharged battery pack back to full capacity. In an unexpected power-off event, a couple of hours charging may get enough battery energy to allow the user to drive home. The speed of the Jupiter scooter is controlled by two potentiometers. One is used to set up its maximum speed, and the other used to vary speed from zero to its specified maximum. The maximum possible speed is 5.0 miles per hour. The Jupiter 50 uses a Curtis controller that is widely used in powered wheelchairs and scooters all over the world, including the Shopriders. Even though the maximum speed is relatively low, a sharp turning may create a tip-over accident. A pair of auxiliary casters are used to prevent such mishaps. If the Jupiter starts to tip over, one of the casters will land on the ground. The landing caster becomes the fourth wheel. It increases the area of support and stabilizes the scooter. The Jupiter 50 is intended to be used by the physically challenged and active elderly people as a mobility assistive device. It enhance user's mobility. People who can walk but not strong enough to endue even a short distance or simply use it for convenience will find that the Jupiter scooters are ideal for them.
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
Physically challenged people and elderly people. Can be used indoors and outdoors.
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)
The resting and comparative study have demonstrated that the Jupiter is substantially equivalent to Legend SC 300. The features of the Jupiter 50 do not pose new safety questions when compared to currently marketed motorized 3-wheel scooters. There are actually fewer safety issues with the Jupiter 50. The Jupiter 50 has been sold in China for more then a year and no safety problems have been raised. The scooter has been tested to the following standards and passed: ISO 7176 / 1, 2, 3, 4, 5, 6, 7, 8, 9 10, 14, and 16. Fire retardantness was tested and passed in accordance to the requirements specified in the British Standard BS5852 which is equivalent to the California Bulletin 116 and 117.
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
JUPITER 50 SCOOTER 510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS
ACEME Technologies International
This 510(k) Summary is submitted, in conjunction with a full submission, this 22nd 1. day of September, 1998, by:
| Company: | ACEME Technologies International
5580 Power Inn Road, Suite I
Sacramento, CA 95820
Tel: (916) 386-2001
Fax: (916) 386-3518 |
| ---------- | ---------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Company Representative: | Tong Zhou, Ph.D.
Vice President & Research Director |
| ------------------------- | -------------------------------------------------------- |
|---|
Date Prepared. September 22, 1998
-
- Device
| Device Name: | Jupiter 50 Scooters |
|---|---|
| Generic Name: | Motorized 3-wheeled Scooter |
| Classification: | Class II |
| Product Code: | 89INI |
| Regulation Number: | 890.3800 |
3. Predicate Device on Which We Base Equivalence
Pride Health Care Legend Scooter 510(k) number -- K926295 Product Code -- 89INI
Description of Device 4.
The Jupiter 50 electric scooter is a mobility assistive device for physically challenged people and elderly people. It is motorized by a 24V DC motor. Two or four 12 volt batteries supply electrical power.
1
Jupiter 50 consists of seven major components: chassis, body covers, transaxle, seat, controller, batteries, and battery charger.
The chassis is divided into three parts: the tiller, the front and the rear chassis. The front and rear chassis are jointed by two pin shafts and secured by two U-shaped pins. They can be assembled or dismantled in less than a minute without using any tools. The tiller is articulated by its upper and lower parts to provide the maximum flexibility. There is a wind shield attached to the handle bar. A unique function of this is to provide a temporary table for holding coffee cup, books, and et. A Jupiter's user can write or work with convenience.
The scooter fairing are made of high-strength plastic - PBS. They cover the chassis and tiller. Their surfaces are painted by baked paint with high finishing. A headlight is installed in the front fairing and two turning lights are in the rear. Those lights enhance drive safety greatly by providing not only signals to other vehicle drivers and pedestrians, but also by lighting road surface and obstacles to avoid collision or other accidents.
A sealed drive train is used in Jupiter scooter. No moving part is exposed. A 24-volt permanent magnetic direct current motor delivers up to 400 Watts power to the system. Motor speed is reduced through gear pairs to its desired wheel shaft speed. The inbedded differential gives the right and the left wheel different speed when the scooter makes turn. All moving parts and bearings inside the gear box are well lubricated by low-viscosity grease. The design of every part is carefully calculated and tested. Such design reduces requirement in maintenance and greatly increases its reliability and ensure a long service life.
An electric dynamic brake is attached to the motor shaft. The braking function is applied when no electric current passes its inductive coils and vanishes when speed control throttle is activated. The Jupiter can stay firmly on a slope of 9 degrees without slipping. This is a very important safety feature every scooter must have in case of sudden electric circuit failure. There is a clutch handle to release the brake locking in order to free wheeling when needed.
Two 30 Ah 12-Volt sealed gel-cell batteries are secured at the top of chassis. A full charge can make a 25 miles travel. The Jupiter 50 also can accommodate four batteries. It increases travel distance to more than 40 miles and lowers the center of gravity of the man-vehicle system. therefore it improves its static and dynamic stability substantially.
The battery charger is built-in with a extension cord. A user can charge the batteries conveniently wherever a power outlet can be found. It takes 6 to 8 hours to charge an almost discharged battery pack back to full capacity. In an unexpected power-off event, a couple of hours charging may get enough battery energy to allow the user to drive home.
The speed of the Jupiter scooter is controlled by two potentiometers. One is used to set up its maximum speed, and the other used to vary speed from zero to its specified maximum. The maximum possible speed is 5.0 miles per hour. The Jupiter 50 uses a Curtis controller that is widely used in powered wheelchairs and scooters all over the world, including the Shopriders.
2
Even though the maximum speed is relatively low, a sharp turning may create a tip-over accident. A pair of auxiliary casters are used to prevent such mishaps. If the Jupiter starts to tip over, one of the casters will land on the ground. The landing caster becomes the fourth wheel. It increases the area of support and stabilizes the scooter.
The Jupiter 50 is intended to be used by the physically challenged and active elderly people as a mobility assistive device. It enhance user's mobility. People who can walk but not strong enough to endue even a short distance or simply use it for convenience will find that the Jupiter scooters are ideal for them.
5. Similarities and Differences to Predicate Device
Our study has demonstrated that the Jupiter is substantially equivalent to the Legend 3-wheeled scooters.
(1). Similarities
The similarities between the Jupiter and the Legend can be identified from their appearances and performances. In principle, both scooters cab be used either indoors and outdoors, and the intended users are the physically challenged people and elderly people. The features built in the Jupiter may be easily found in those Legend.
(a). Both the Jupiter and Legend are intended to be used by physically challenged people and elderly people.
(b). Both can be used indoors and outdoors.
(c). The Jupiter 50 and Legend scooters both use a 24 volt DC permanent magnetic motor with sealed transaxle drive unit.
(d). Both use a disk-type coil-activated electric brake
(e). The motor control boards are the same with respect to the power FET design.
(f). True regenerative and dynamic braking provide complete downhill and deceleration speed control in both scooters.
(g). Each has an industrial-typical wig-wag potentiometer, forward/reverse speed control, along with a speed limit potentiometer.
(h). The maximum forward speeds in both scooters are in the limit of 6 miles per hour specified by ANSI/RESNA.
(i). The maximum reverse speeds in both scooters are designed to be 60% of the their maximum forward speeds, respectively.
3
(i). Speeds of both scooters can be controlled from zero to their maximum
(k). Both scooters feature upholstered seats with removable armrests and height adjustment capability. Seats on each swivel 360 degrees.
(1). All major dimensions are similar.
(m). Each uses two 12-volt U-1 type batteries as their power source, and each uses commercially available built-in battery charger.
(n). The console on each has a battery indicator, horn switch or button, power switch, and speed limit potentiometer.
(o). The range of each is almost the same.
(2). Differences
There are some differences between the Jupiter and the Legend. Those differences neither are substantial, nor cause any safety concerns. As matter of fact, the Jupiter have been improved by introduced some features, such as head light and turning lights, four battery option, and bigger front wheels.
| Jupiter 50 | Legend | |
|---|---|---|
| Wheels | all 10" tires | one 9"/two 10" |
| Battery | optional 4 batteries | no option |
| Lights | Front light | |
| Rear signal lights | no | |
| no | ||
| Windshield/table | yes | no |
| Seat Post | Gas-filled cylinder for auto height | |
| adjustment and cushioned ride (option) | no |
To summarize the similarities and differences, Table 1 tabulate some important structure and performance data.
4
| Jupiter 50 | Legend SC 300 | |
|---|---|---|
| Number of wheels | 3 | 1/3 |
| Wheel size | 3 x 10" | 2 Rear 10", Front 9" |
| Width | 600 mm (24") | 24" |
| Length | 1200 mm (47.2") | 47" |
| Ground Clearance | 100 mm (4") | 4.25" |
| Weight w/o batteries | 107 lb. | 105 lb.. |
| Seat style | fish-on | fish-on |
| Speed | 0 - 8.0 km (0 -5.0 miles) | 0 - 5.25 mph |
| Number of Batteries | 2 or 4 | 2 |
| Travel Range(varies with | ||
| terrain and weight of rider) | 40 km (25 miles) | |
| 75 km (47 miles) | 25 miles | |
| Motor Size, Count. hp. | 400 W (0.55 hp) | 0.6 hp |
| Maximum battery size | 4 x 12V-30Ah | 2 x 12V-30Ah |
| Grade climbable | 12 degrees | 15 degrees |
| Carrying Capacity | 250 lb.. | 250 lb.. |
| Number of disassembly parts | 5 | 5 |
| Weight of heaviest part | 55 lb. | 49 lb.. |
| Auxiliary Safety Casters | 2 | None |
| Dynamic Electric Brake | Yes | Yes |
| Turning lights | Yes | Optional |
| Head Light | Yes | Optional |
Table 1 Comparison of Jupiter 50 to Legend SC 300
Safety and Effectiveness Information 6.
The resting and comparative study have demonstrated that the Jupiter is substantially equivalent to Legend SC 300. The features of the Jupiter 50 do not pose new safety questions when compared to currently marketed motorized 3-wheel scooters. There are actually fewer safety issues with the Jupiter 50. The Jupiter 50 has been sold in China for more then a year and no safety problems have been raised.
The scooter has been tested to the following standards and passed:
ISO 7176 / 1, 2, 3, 4, 5, 6, 7, 8, 9 10, 14, and 16.
Fire retardantness was tested and passed in accordance to the requirements specified in the British Standard BS5852 which is equivalent to the California Bulletin 116 and 117.
5
Image /page/5/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
Tong Zhou, Ph.D. Vice President and Research Director Aceme Technologies International 5580 Power Inn Road, Suite 1 Sacramento, California 95820
K983405 Re : ACEME Jupiter Scooter, Motorized 3-Wheeled Trade Name: Jupiter 50 K983407 ACEME Jupiter Scooter, 4-Wheeled Jupiter 50F Trade Name: Requlatory Class: II Product Code: INI September 23, 1998 Dated: September 28, 1998 Received:
Dear Dr. Zhou:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
6
Page 2 - Tong Zhou, Ph.D.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosures
7
II. Indication for Use Statement
510(k) Number (if known):
Device Name: Jupiter 50 Motorized 3-Wheeled Vehicle
Indications for Use
Used as an indoor and outdoor mobility assistive device. Never used as a transportation tool on highways and freeways.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
( Division of General Restorative Devices)
1988 -510(k) Number .
Over-The Counter Use X
Prescription Use (Per 21 CFR 801.109) OR