(223 days)
Based on the information provided in the {{overview}} section, I can't definitively say whether the device contains an AI model.
Here's why:
- The
{{overview}}section is a placeholder. Without the actual content of the{{overview}}section, I have no information about the device's capabilities, features, or technical specifications. - AI is a broad term. AI models can be implemented in various ways, from simple machine learning algorithms to complex neural networks running on dedicated hardware. The presence of AI might not be immediately obvious from a general overview.
To determine if the device contains an AI model, I would need to see the specific details in the {{overview}} section. Look for key phrases or descriptions that might indicate the use of AI, such as:
- Machine learning capabilities
- Neural networks
- Computer vision
- Natural language processing (NLP)
- Predictive capabilities
- Adaptive learning
- Intelligent features
- Processing of large datasets to make decisions/predictions
Please provide the content of the {{overview}} section, and I can give you a more informed answer.
No
The device is a mobility aid for transportation and does not perform any therapeutic function to treat or alleviate a medical condition.
No
The device is described as a mobility scooter intended to provide transportation, and its description focuses on mechanical and electrical parameters, not on diagnosing medical conditions.
Analyzing the provided text to determine if the device is software-only.
{{overview}}
Now, based on the analysis of the text:
No
The overview explicitly states the device includes a patient-worn smart device (Apple Watch) and a clinical management portal (web-based). While the portal is software, the Apple Watch is a hardware component essential to the device's intended use (monitoring physiological parameters). Therefore, it is not a software-only medical device.
Based on the overview provided, to determine if the device is an In Vitro Diagnostic (IVD), I need to evaluate the intended use of the device.
Generally, a device is considered an IVD if it is intended by the manufacturer to be used:
- In vitro (outside the body).
- For the examination of specimens, including blood, tissue, and urine, derived from the human body.
- To provide information for diagnostic, monitoring or compatibility purposes concerning a physiological or pathological state, a congenital abnormality, or the effect of therapeutic measures.
To give you a definitive answer, please provide the following information about the device from the overview:
- What is the intended use of the device? (e.g., What is the device designed to do? What information does it gather?)
- Does the device analyze specimens taken from the human body? (e.g., blood, urine, saliva, tissue)
- Is the analysis performed outside the body?
- Is the information obtained for the purpose of diagnosis, monitoring, screening, or prognosis of a medical condition?
Once you provide this information from the overview, I can tell you with much more certainty if the device is an IVD.
Here are some examples to help illustrate:
- Likely IVD: A device that analyzes a blood sample to measure glucose levels to help diagnose diabetes.
- Likely IVD: A kit used to detect antibodies in a urine sample to screen for a viral infection.
- Not an IVD: A device that measures blood pressure on a patient's arm (this is an in-vivo measurement).
- Not an IVD: A piece of equipment that sterilizes surgical instruments (this is not for diagnostic purposes).
Please share the relevant details from the overview so I can properly classify the device.
N/A
Intended Use / Indications for Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Product codes
INI
Device Description
The Mobility Scooter, is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. The scooter is classified as type Class A with 120 kg including occupant and any carried items weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists of sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and two lead-acid batteries with an off-board battery charger. It is powered by rechargeable battery with 15 km theoretical distance range which maximum speed up to 7 km/h.
The motor of electric wheelchair is DC24V 120W; the battery is 24V 12AH,Lead-acid battery; the charger is DC 24V, 2A. Max. loading can not be over than 265lbs(120kg). Max. distance of travel on the fully charged battery is 19.2km and Max. speed forward is 1.94m/s (7 km/h). The braking time is about 1.93s, and the braking distance is 1.16m.
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
- ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
- ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
- ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- ISO 7176-11: 2012 Wheelchairs - Part 11: Test dummies
- ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
- ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
- ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- ISO 16840-10:2021 Wheelchair seating Part 10: Resistance to ignition of postural support devices — Requirements and test method
- ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
- ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- EN 12184 :2014 Electrically powered wheelchairs, scooters and their chargers- Requirements and test methods
Biocompatibility of patient-contacting parts:
Patient-contacting material are carried out biocompatibility assessment in accordance with lSO 10993-1: 2018, including:
- Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- Skin Sensitization per ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization.
- Irritation per ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests For Irritation.
Key Results: The conclusions drawn from the comparison and analysis above demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicated device in K201196 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
FDA Premarket Notification (510(k)) Letter
Page 1
May 7, 2025
Wuyi Aichi Industry & Trade Co., Ltd.
℅ Boyle Wang
Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong
Shanghai, 200120
China
Re: K242975
Trade/Device Name: Mobility Scooter (Model X-01, X-02)
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized Three-Wheeled Vehicle
Regulatory Class: Class II
Product Code: INI
Dated: April 7, 2025
Received: April 7, 2025
Dear Boyle Wang:
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 (the 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 available 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.
Page 2
K242975 - Boyle Wang Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K242975 - Boyle Wang Page 3
assistance/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,
Julia E. Slocomb -S
2025.05.07 15:06:14 -04'00'
for Heather Dean, PhD
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
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K242975
Device Name
Mobility Scooter (Model X-01, X-02)
Indications for Use (Describe)
It is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
1 of page 8
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's information
Name: Wuyi Aichi Industry&Trade Co.,Ltd.
Address: Yongwu road, Southeast Industrial Zone, Wuyi, Zhejing Province, 321200 China
Tel: 86-13506793848
Fax: 86-579-87486410
Contact: Mr.LYU Wei
Date of Preparation: Sep.07, 2024
Designated Submission Correspondent
Mr. Boyle Wang
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China
Tel: +86-21-50313932
Email: Info@truthful.com.cn
2.0 Device information
Trade name: Mobility Scooter
Common name: Scooter
Classification name: Motorized Three-Wheeled Vehicle
Model(s): X-01, X-02
3.0 Classification
Production code: INI
Regulation number: 21 CFR 890.3800
Classification: Class II
Panel: Physical Medicine
4.0 Predicate device information
Manufacturer: Nanjing Jin Bai He Medical Apparatus Co., Ltd.
Trade/Device: Scooter (Model: FDB01)
Page 6
510(k) Summary
2 of page 8
510(k) number: K201196
5.0 Indication for Use Statement
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
6.0 Device description
The Mobility Scooter, is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. The scooter is classified as type Class A with 120 kg including occupant and any carried items weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists of sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and two lead-acid batteries with an off-board battery charger. It is powered by rechargeable battery with 15 km theoretical distance range which maximum speed up to 7 km/h.
The motor of electric wheelchair is DC24V 120W; the battery is 24V 12AH,Lead-acid battery; the charger is DC 24V, 2A. Max. loading can not be over than 265lbs(120kg). Max. distance of travel on the fully charged battery is 19.2km and Max. speed forward is 1.94m/s (7 km/h). The braking time is about 1.93s, and the braking distance is 1.16m.
7.0 Summary of Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
- ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
- ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
- ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
Page 7
510(k) Summary
3 of page 8
- ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- ISO 7176-11: 2012 Wheelchairs - Part 11: Test dummies
- ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
- ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
- ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- ISO 16840-10:2021 Wheelchair seating Part 10: Resistance to ignition of postural support devices — Requirements and test method
- ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
- ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- EN 12184 :2014 Electrically powered wheelchairs, scooters and their chargers- Requirements and test methods
Biocompatibility of patient-contacting parts
Patient-contacting material are carried out biocompatibility assessment in accordance with lSO 10993-1: 2018, including:
- Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- Skin Sensitization per ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization.
- Irritation per ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests For Irritation.
8.0 Summary of Clinical Testing
No clinical study implemented for the scooter.
9.0 Technological Characteristic Comparison Table
Page 8
510(k) Summary
4 of page 8
Table1-General Comparison
| Item | Subject device | Predicate device | Remark |
|---|---|---|---|
| Product Code | INI | INI | Same |
| Regulation No. | 21 CFR 890.3800 | 21 CFR 890.3800 | Same |
| Class | II | II | Same |
| Product name | Scooter (Model: X-01, X-02) | Scooter (Model: FDB01) | - |
| 510(k) No. | K242975 | K201196 | - |
| Intended Use/Indication for Use | It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. | It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. | Same |
| Use environment | Indoor and outdoor use | Indoor and outdoor use | Same |
| Patient Population | This product is suitable for disabled people with mobility difficulties and elderly people. | This product is suitable for disabled people with mobility difficulties and elderly people. | Same |
| Product structure | It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists of sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and two lead-acid batteries with an off-board battery charger. | It has a base with metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, 2 rechargeable lead-acid cell with an off-board charger. | Similar |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Number of wheels | 4 | 4 | Same |
| Main frame material | Aluminium alloy | Aluminium alloy | Same |
| Motor | Brushless motor, DC24V* 250W*1 pcs | Brush differential rear axle. 24V *180W | Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Battery | 12V12Ah Lead-acid cell, 2 pcs | 24V 6AH Lithium-ion, 2 pcs | |
| Battery charger | Off-board charger Input: 100-240 VAC Output: DC 24V, 2A | Off-board charger Input: 100-240 VAC Output: DC 24V, 6 Amp |
Page 9
510(k) Summary
5 of page 8
Table2 Performance Comparison
| Item | Subject Device | Predicate Device K201196 | Remark |
|---|---|---|---|
| Dimensions (mm) | 1080 X650 X940 | 1050 X 550 X 870 | Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Folded dimensions (mm) | 1080x650x500 | 480 x550 x790 | Minor differences in the folded dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Weight, w/ Battery | 97lbs. /44kg | 63.1lbs. /29 kg | The difference will not raise any new safety and effectiveness concerns. |
| Frame design | Foldable/ The scooter is driven by electricity scooter, is a transportation tool and auxiliary tools for the purpose of walking, without removing the battery can be folded, easy to carry and storage. | Foldable/ Electric scooter is driven by electricity scooter, is a transportation tool and auxiliary tools for the purpose of walking, without removing the battery can be folded, easy to carry and storage. | Same |
| Seating Attachment - integrated, power base, specialty power | Without any seat accessories (integrated, power base, dedicated power supply) | Without any seat accessories | Same |
| Folding mechanism | A foldable seat frames (The backrest could be folded to seat) | Seat can be folded; battery can be dismantled；The frame can be folded back and forth | Same |
| Front wheel(inch) | 8 (Solid tire) | 7 (Solid tire) | Larger size of the front wheel. The difference will not raise any new safety and effectiveness concerns. |
| Rear tire (inch) | 8 (Solid tire) | 8 (Solid tire) | Same |
| Anti-tip Wheels (inch) | 2.0 | 2.5 | Same |
Page 10
510(k) Summary
6 of page 8
| Cruising Range(km) | 15 | Not Publicly Available | The difference will not raise any new safety and effectiveness concerns. |
|---|---|---|---|
| Obstacle climbing(mm) | 40 | 60 | The smaller height in the obstacle climbing will not impact the safety and effectiveness of the subject device. |
| Ground clearance | 40mm | 50mm | The device has been tested according to ISO7176 series standards and the test records support its safety and effectiveness. |
| Static stability forward | 15.6° | 30° | Both of the devices are evaluated according to standard ISO 7176-1:2014, so the different static stability will not impact the safety and effectiveness |
| Static stability rearward | 9.5° | 20.1° | |
| Static stability sideways | 14.1° | 15.3° | |
| Max. loading (kg) | 265lbs(120kg) | 265lbs (120kg) | Same |
| Min. Turning radium | 1400mm | 1200mm | The little difference in the turning radius will bring more convenience when it turns. The difference will not raise any new safety and effectiveness concerns. |
| Minimum braking distance | 1.16m for the speed of 7km/h 1.93s | 1.1 m for the speed of 6km/h 1s | Similar |
| Max Speed Forwards | 1.94m/s (7 km/h) | 1.67m/s (6 km/h) | The devices are evaluated according to standard ISO 7176-6:2018, so the different will not impact the safety and effectiveness |
| Max. Speed Backward | 0.93 m/s (3.3 km/h) | 0.83m/s (3 km/h) | The devices are evaluated according to standard ISO 7176-6:2018, so the different will not impact the safety and effectiveness |
| Controller | British PG Controller R-series | British PG Controller PG45A | Although different controller is used, both the control system, including the |
Page 11
510(k) Summary
7 of page 8
electromagnetic brakes and the user interface are similar. Both devices have the same user interface, the patient uses the foldable tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop. The speed mode of the both devices was single mode and the speed control dial can control the maximum speed. Both of the control systems are evaluated according to standard ISO 7176-14:2008 and software validation requirement and there are no new safety and effectiveness concerns due to the difference.
| Wheel Lock (type) | Electromagnetic brake | Electromagnetic brake | Same |
|---|
Table3 Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Materials contacting user | Armrest: PU foam Backrest: PVC Artificial Leather Seat: PVC Artificial Leather Joystick: Nylon + 30% Glass fiber Handle cover: PVC Footrest: TPR Footrest decoration: ABS | Armrest: PU Foamed; Backrest/seat: Leather package Footplates: ABS plastics | Biocompatibility evaluation has been carried out per ISO 10993-1. There are no new safety and effectiveness concerns due to the difference. |
| Biocompatibility of materials contacting user | Comply with ISO 10993-1, FDA Guidance, Tests included Cytotoxicity Test (ISO 10993-5:2009) Sensitization Test (ISO 10993-10:2021) Intracuaneous Reacitivity Test (ISO 10993-23:2021) | Comply with ISO 10993-1, FDA Guidance, Tests included Cytotoxicity (ISO 10993-5:2009), Sensitization and Intracutaneous Reactivity (ISO 10993-10:2010) | Same |
Page 12
510(k) Summary
8 of page 8
Summary of substantial equivalence discussion:
Despite of the above differences, the two devices all completed the performance tests in accordance with ISO 7176 series standards. There are no safety and effectiveness aspects concerned. In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicated device in K201196 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.