(186 days)
Not Found
No
The description focuses on the mechanical and electrical components of a mobility scooter and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device provides transportation and mobility assistance, but it does not treat, diagnose, or prevent any medical condition or disease.
No
The device description indicates that the ATTO Mobility Scooter is used for transportation and mobility, not for diagnosing medical conditions or diseases.
No
The device description clearly outlines a physical, electrical battery-powered scooter with a motor, wheels, and braking system, indicating it is a hardware device.
Based on the provided information, the Moving Life ATTO Mobility Scooter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide transportation for disabled or elderly individuals. This is a mobility aid, not a diagnostic tool.
- Device Description: The description details a physical scooter for transportation, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The ATTO Mobility Scooter does not fit this definition.
N/A
Intended Use / Indications for Use
ATTO Mobility Scooter is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
ATTO Mobility Scooter is an electrical battery powered, three-wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The ATTO is a collapsible electric scooter which has a front-wheel brushless DC hub motor. The scooter can be collapsed in 12 seconds, and can also be disassembled with ease.
The scooter controlled through a thumb throttle and protected by an electronic-release brake system, has a driving range of 15 km between charges. It is capable of carrying a driver weighing up to 100 kg. It moves in both directions, and can handle a 6° slope. It can come to a full stop within 1.1m when on a horizontal plane and within 2.2 m when on a 6° slope.
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 person
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)
Moving Life ATTO Mobility Scooter is designed and tested in accordance with the ISO 7176 standard series, including all relevant sections i.e. Section 2, Section 3, Section 4, Section 5, Section 6, Section 7, Section 9, Section 10, Section 10, Section 11, Section 13, Section 14, Section 15, Section 16, and Section 21. The battery and charger conform to the IEC 62133 standard. All Performance tests met the predetermined acceptance values. The Movinq Life ATTO Mobility Scooter functioned as intended and its functionality observed was as expected.
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
Image /page/0/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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 4, 2016
Moving Life Ltd. % Mr. Igor Naroditsky RA adviser Igor Naroditsky, Medical Device Certification LLC Emeq Hashalom 26/2 Yogneam Illit, 20692 Israel
Re: K160909
Trade/Device Name: ATTO Mobility Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: July 30, 2016 Received: August 8, 2016
Dear Mr. Naroditsky:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -A
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160909
Device Name ATTO Mobility Scooter
Indications for Use (Describe)
ATTO Mobility Scooter is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
K160909
Contact Details A.
Applicant Name: Nino A. Ransenberg, Chairman Moving Life Ltd 2 Ha'ofe St. Kadima, lsrael 6092000
Contact Name: Igor Naroditsky, RA Adviser Phone: + 972 54 4384386 Fax: + 972 73 3913 998
B. Device Name:
Trade Name: ATTO Mobility Scooter
Model: Type I
Common Name: Vehicle, Motorized 3-Wheeled
Classification Name: Motorized three-wheeled vehicle; INI; 890.3800
C. Legally Marketed Predicate Device(s)
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K110165 | INI | Luggie | Freerider Corporation |
D. Device Description
ATTO Mobility Scooter is an electrical battery powered, three-wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The ATTO is a collapsible electric scooter which has a front-wheel brushless DC hub motor. The scooter can be collapsed in 12 seconds, and can also be disassembled with ease.
The scooter controlled through a thumb throttle and protected by an electronic-release brake system, has a driving range of 15 km between charges. It is capable of carrying a driver
4
weighing up to 100 kg. It moves in both directions, and can handle a 6° slope. It can come to a full stop within 1.1m when on a horizontal plane and within 2.2 m when on a 6° slope.
ய் Intended Use/indications for use
The Moving Life ATTO Mobility Scooter is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Substantial Equivalence Comparison ட்
The Moving Life ATTO Mobility Scooter is as safe and effective as the Luggie (K110165). The Moving Life ATTO Mobility Scooter has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Moving Life ATTO Mobility Scooter and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Moving Life ATTO Mobility Scooter is as safe and effective as the Luggie (K110165). Thus, the ATTO Mobility Scooter is substantially equivalent.
| Model | ATTO Mobility Scooter | Luggie |
|---|---|---|
| K number | K160909 | K110165 |
| Indication for Use | The Moving Life ATTO Mobility | |
| Scooter is an indoor/outdoor | ||
| scooter that provides | ||
| transportation for a disabled or | ||
| elderly person. | The device provides | |
| transportation for an elderly or | ||
| disabled person. It can be | ||
| used in variety of indoor and | ||
| outdoor settings. | ||
| Front wheel size | 203 x 27 mm | 200 x 50 mm |
| Rear wheel size | 228 x 57 mm | 200 x 50 mm |
| Ground clearance | 100 mm | 64 mm / 2.5 inches |
| Number of wheels | 3 | 3 (double front wheel) |
| Length | 1200 mm | 1000 mm |
| Width | 560 mm | 455 mm / 18 inches |
| Max load | 100 kg | 114 kg / 250 pounds |
| Required width of angled | ||
| corridor | 1000 mm | 762 mm |
| Turn radius | 135.0 cm | 103.75 cm / 40.85 inches |
| Battery | Li-Ion battery 48V 5.2 ah | Li-Ion battery 24V 8.5 ah |
| Charger | AC input.100-240 volt, 50/60Hz, | |
| DC output 54.6 volt. 2 Amp for | ||
| lithium-ion battery | AC input.100-240 volt, | |
| 50/60Hz, DC output 24 volt. 5 | ||
| Amp for li-ion battery | ||
| Type of controller | Microprocessor based, | |
| proportional and integral | ||
| controller which continually | ||
| monitors the ATTO systems. | Microprocessor based which | |
| continually monitors the | ||
| Luggie scooter's systems | ||
| Maximum speed (forward) | 6.4 km/h | 6 km/h |
| Maximum speed (reverse) | 4 km/h | 3.52 km/h |
| Travel distance | 15 km | 18 km |
| Electrical System: | 48 volt DC | 24 volt DC |
| Drive system | Front wheel, direct drive. | Rear wheel, direct drive via |
| sealed drive axle | ||
| Motor | 48 volt DC, Brushless electric | |
| motor with 3 phases & sensors | 24 volt DC. Permanent | |
| magnet totally enclosed for | ||
| outdoor use. Internal brushes. | ||
| 3.0 Amp (no load) | ||
| Brake | Spring Applied Electrical | |
| Released Brakes with freewheel | ||
| mode | Automatic dynamic | |
| regenerating braking system | ||
| with spring activated | ||
| magnetic solenoid parking | ||
| brake and freewheel facility. | ||
| Tiller | Adjustable locking for driving | |
| comfort | Same | |
| Speed Control | PID velocity and current control | Proportional state of the art |
| design for safety and smooth | ||
| operation incorporated with | ||
| 'Fault' diagnosis. | ||
| Seat | Folding seat | Contoured adjustable seat |
| with height adjustment. | ||
| Armrest are optional with | ||
| multiple width adjustments |
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G. Non-clinical Testing
Moving Life ATTO Mobility Scooter is designed and tested in accordance with the ISO 7176 standard series, including all relevant sections i.e. Section 2, Section 3, Section 4, Section 5, Section 6, Section 7, Section 9, Section 10, Section 10, Section 11, Section 13,
6
Section 14, Section 15, Section 16, and Section 21. The battery and charger conform to the IEC 62133 standard. All Performance tests met the predetermined acceptance values. The Movinq Life ATTO Mobility Scooter functioned as intended and its functionality observed was as expected.
H. Clinical Testing
No clinical testing is included in this submission.
. Technological Characteristics
An electrical battery powered, three-wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings is the technological principle for both the subject and predicate devices. It is based on the use of electrical motor powered by rechargeable battery through electrical controller mounted on same three wheel platform. Thus, based on the following similar technological elements:
- . DC motor, is used to rotate the wheel forward or backward.
- Li lon rechargeable battery, to power the system.
- . The controller provides a movement and speed control.
- Three wheel based platform provides a stable and flexible platform for indoor and outdoor use.
- Brake system utilizes a same dynamic principles and technology.
- Both systems are operated via two handles tiller.
The following technological differences exist between the subject and predicate devices:
- The subject device reach maximum 15 kilometer of travel distance in comparing to 18 in the predicate.
- The subject device utilizes 48 V 5.2 ah Li-Ion battery in comparing to 24 V 8.5ah at the predicate.
- The subject device has only off board charger in comparing to the On and Off o board charger attached to the predicate device.
- The subject device has 48 V electrical systems in comparison to the 24V in the predicate.
- The subject device use a front wheel driving system in comparing to rear wheel driving in the predicate.
- . A speed control archived through PID velocity and current control in the subject device in compare to the proportional state of the art design for safety and smooth operation incorporated with 'Fault' diagnosis in the predicate.
7
At a high level, the subject and predicate devices are based on the following same technological elements: Both are electric scooters that are battery operated and have automatic braking systems. Batteries and battery chargers are provided with each scooter. Performance parameters of the devices are very similar. There are some minor technological differences between the proposed ATTO Mobility Scooter and the commercially available Luggie (K110165). None of these differences raise new issues of safety and effectiveness.
The additional and minor technology differences between the proposed ATTO Mobility Scooter Type I and its predicate, the Luggie (K110165) is folding mechanism of the proposed device and the face that it can be disassembled into two parts. The proposed device has a mechanism retracts the rear wheels while folding the seat. In addition, the proposed device has a separation mechanism that allows the disassembly of the vehicle to two main parts.
J. Conclusion
The safety and effectiveness of the ATTO Mobility Scooter were demonstrated by the testing in compliance with national and international standards. The intended use, basic technology, and the features of the ATTO Mobility Scooter are similar to the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.