(254 days)
Not Found
No
The description focuses on the mechanical and electrical aspects 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
Explanation: The device is described as a mobility scooter for transportation, not for treating or preventing a disease or condition.
No
The device description indicates that the ATTO Mobility Scooter is for transportation and mobility, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, electrical, and mechanical device (scooter) with hardware components like a motor, battery, and braking system. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide transportation for a disabled or elderly person. This is a physical mobility aid, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a physical scooter with a motor, wheels, and controls. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims
- Performance metrics like sensitivity, specificity, AUC, etc. (which are relevant to diagnostic accuracy)
The ATTO Mobility Scooter is clearly a medical device, but it falls under the category of a mobility aid, not an in vitro diagnostic device.
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 up to 20 km between charges. It is capable of carrying a driver weighing up to 136 (for ATTO MAX) kg. It moves both directions and handles 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.
The differences between the ATTO Mobility Scooter and its predicates are:
- Introduction of the two additional models, ATTO SPORT, and ATTO SPORT MAX with
- Additional Manual Front Wheal brake for extra safety
- Software Speed control feature (in ATTO SPORT, and ATTO SPORT MAX only)
- Enhanced LCD display
- Extra wide rear wheel
- Rear light handle
- Powerful LED Headlights
- Shock-absorbing airless NPT tires
- Regenerative braking control system
- Modified controller
- Modified charger and battery
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
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)
Non-clinical Testing:
Moving Life ATTO Mobility Scooter is designed in accordance with the ISO7176 series including all relevant sections i.e., Section 2, Section 3, Section 4, Section 5, Section 6, Section 9, Section 10, Section 11, Section 14, Section 14, Section 16, Section 21 and Section 25, etc. ATTO performance and safety testing is conducted according to EN 12184:2014. All Performance testing met the predetermined acceptance values. The Moving Life ATTO Mobility Scooter functioned as intended and its functionality observed was as expected.
Clinical Testing:
No clinical testing is included in this submission.
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
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May 19, 2023
Moving Life Ltd Igor Naroditsky RA Adviser Havat Alenby Netzer Sereni, 7039500 Israel
Re: K222703
Trade/Device Name: ATTO Mobility Scooter (ATTO):ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 17, 2023 Received: April 17, 2023
Dear Igor 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tushar Bansal -S
Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K222703
Device Name
ATTO Mobility Scooter (ATTO) ATTO Mobility Scooter (ATTO SPORT) ATTO Mobility Scooter (ATTO SPORT MAX)
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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3
510(k) SUMMARY (K222703)
ATTO Mobility Scooter
A. Contact Details
Applicant Name: Moving Life Ltd Havat Allenby, Netzer Sereni, 7039500 Israel Contact Name: Igor Naroditsky, Regulatory Adviser Phone: + 972 54 4384386 Date Prepared: Aug 15, 2022
B. Device Name:
Trade Name: ATTO Mobility Scooter
Models: ATTO, ATTO SPORT, ATTO SPORT MAX
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 |
|---|---|---|---|
| K160909 | INI | ATTO Mobility Scooter | Moving Life Ltd |
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 up to 20 km between charges. It is capable of carrying a driver weighing up to 136 (for ATTO MAX) kg. It moves both directions and handles 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.
The differences between the ATTO Mobility Scooter and its predicates are:
- । Introduction of the two additional models, ATTO SPORT, and ATTO SPORT MAX with
- । Additional Manual Front Wheal brake for extra safety
4
- Software Speed control feature (in ATTO SPORT, and ATTO SPORT MAX only) ।
- -Enhanced LCD display
- -Extra wide rear wheel
- -Rear light handle
- Powerful LED Headlights -
- -Shock-absorbing airless NPT tires
- -Regenerative braking control system
- Modified controller -
- -Modified charger and battery
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.
F. Substantial Equivalence Comparison
The proposed ATTO Mobility Scooter is as safe and effective as the ATTO Mobility Scooter (K160909) by Moving Life. The Scooter has the same intended uses and same 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 ATTO Mobility Scooter (K160909) by Moving Life. Thus, the proposed ATTO Mobility Scooter is substantially equivalent.
| Model | Predicate ATTO Mobility
Scooter (K160909) | Proposed ATTO Mobility Scooter
(K222703) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Moving Life ATTO Mobility
Scooter is an indoor/outdoor
scooter that provides
transportation for a disabled or
elderly person. | The Moving Life ATTO Mobility
Scooter is an indoor/outdoor
scooter that provides
transportation for a disabled or
elderly person. |
| Front wheel size | 203 X 27 mm | 8 in |
| Rear wheel size | 228 X 57 mm | 9 in |
| Ground clearance | 100 mm | 100 mm |
| Number of wheels | 3 | 3 |
| Length | 1200 mm | 1200 mm |
| Width | 560 mm | 560 mm |
| Max load | 100 kg | 120 kg for ATTO and ATTO Sport.
136 kg for ATTO SPORT MAX |
| Required width of
angled corridor | 1000 mm | 1000 mm |
G. Substantial Equivalence Chart
5
| Model | Predicate ATTO Mobility
Scooter (K160909) | Proposed ATTO Mobility Scooter
(K222703) |
|----------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Turn radius | 1350 mm | 1350 mm |
| Battery | Li-Ion battery 48V 5.2 ah | Li-ion Battery 5.2 Ah; DC 48 V;
249.6 Wh |
| 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 54.6 volt. 2
Amp for lithium-ion battery |
| Type of controller | Microprocessor based,
proportional and integral
controller which continually
monitors the ATTO systems. | Microprocessor based,
proportional and integral controller
which continually monitors the
ATTO systems. |
| Maximum speed
(forward) | 6.4 km/h | 6.4 km/h for ATTO and ATTO
Max. 9.6 km/h for Max SPORT |
| Maximum speed
(reverse) | 4 km/h | 4 km/h |
| Travel distance | 15 km | 20/17 km |
| Electrical System: | 48-volt DC | 48-volt DC |
| Drive system | Front wheel, direct drive. | Front wheel, direct drive. |
| Motor | 48-volt DC, Brushless electric
motor | 48-volt DC, Brushless electric motor |
| Brake | Spring Applied Electrical
Released Brakes with
freewheel mode | Spring Applied Electrical
Released Brakes with freewheel
mode with regenerative braking
control system. Additional front
disk brake for extra safety |
| Tiller | Adjustable locking for driving
comfort | Adjustable locking for driving
comfort |
| Braking Time | Not publicly available | .5s |
| Braking Distance | Not publicly available | 1.1m |
| Speed Control | Velocity and current control | Velocity and current control |
| Seat | Folding seat | Folding seat |
H. Non-clinical Testing
Moving Life ATTO Mobility Scooter is designed in accordance with the ISO7176 series including all relevant sections i.e., Section 2, Section 3, Section 4, Section 5, Section 6, Section 9, Section 10, Section 11, Section 14, Section 14, Section 16, Section 21 and Section 25, etc. ATTO performance and safety testing is conducted according to EN 12184:2014. All Performance testing met the predetermined acceptance values. The Moving Life ATTO Mobility Scooter functioned as intended and its functionality observed was as expected.
l. Clinical Testing
No clinical testing is included in this submission.
J. Technological Characteristics
ATTO Mobility Scooter is a same as the commercially available ATTO Mobility Scooter (K160909) by Moving Life and based on the same fundamental technology as the predicate devices. Both are
6
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 technology differences between the proposed ATTO Mobility Scooter and the commercially available ATTO Mobility Scooter (K160909) by Moving Life. None of these differences raises new issues of safety and effectiveness.
K. 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. No new issues of safety and effectiveness is raised by the differences between the proposed ATTO Mobility Scooter and its predicate devices.