(54 days)
"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."
The product is a Mobility Scooter which provides transport for the disabled and the elderly and to be used both indoors and outdoors.
This scooter is a battery powered four wheeled vehicle. It consists two Lead-acid batteries (in the battery box) with an off-board battery charger, frame, a seat, a back support, control panel (including the key switch, throttle control lever, horn button, speed adjustment dial, and the battery condition meter), two foldable handles, two rear drive wheels with motor/ e-magnetic brake components, two front wheels, anti-tip devices, an external battery charger, a control panel and a motor controller. For convenience of transportation and reduction of possible damage, the battery and the seat unit can be dismantled and separately packaged.
The front wheels of the scooter are 8 inches and the rear wheels are 9 inches.
The motor of the scooter is 24VDC,150W,4200RPM; the Lead-acid Battery is 12 V, 22 Ah, 18.7 Ah; the charger is 24V/2A.
Max. loading cannot be over than 180kg.
The maximum distance travelled with a fully charged battery is 17.5km and the maximum forward speed is 1.6m/s(5.8km/h).
Braking time is less than 2 seconds, braking distance is ≤1.0 meters.
This document is an FDA 510(k) Clearance Letter for a Mobility Scooter (MS160C). It is not an AI/ML medical device, and therefore does not contain the information typically associated with studies proving the performance of an AI/ML algorithm.
The request asks for details like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance," which are specific to the evaluation of AI/ML software. This information is irrelevant to a physical device like a mobility scooter.
Therefore, I cannot provide the requested information as it is not present in the provided document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing against established standards (ISO, IEC).
Here's why each point in your request cannot be answered based on the provided text:
- A table of acceptance criteria and the reported device performance: While the document lists performance characteristics in "Table 2 - Performance Comparison", these are not presented as "acceptance criteria" in the sense of accuracy/sensitivity/specificity targets for an AI algorithm. Instead, they are comparisons to a predicate device and compliance with established ISO standards. I can extract performance characteristics, but not "acceptance criteria" for an AI model.
- Sample sized used for the test set and the data provenance: Not applicable. This refers to data for an AI model. The mobility scooter underwent physical product testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are for AI model validation.
- Adjudication method: Not applicable. Adjudication is for resolving discrepancies in AI model output or expert readings.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. MRMC studies are for evaluating AI's impact on human performance in diagnostic tasks.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical product, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" is a concept for AI model training and validation.
- The sample size for the training set: Not applicable. This refers to data for an AI model.
- How the ground truth for the training set was established: Not applicable. This refers to data for an AI model.
However, I can extract information related to the device's performance testing based on the provided document:
Study that proves the device meets requirements (Non-Clinical Testing):
The study was a series of non-clinical tests conducted to verify that the proposed device (Mobility Scooter MS160C) met all design specifications and was substantially equivalent (SE) to the predicate device (Mobility Scooter Model: W3468, K220207).
1. Table of Acceptance Criteria (as reported performance against standards, not AI-specific criteria) and the Reported Device Performance:
The document describes compliance with various ISO and IEC standards as the basis for demonstrating safety and effectiveness. The "acceptance criteria" are implied by adherence to these standards, and the "reported performance" is demonstrated by the test results confirming this compliance.
Key Performance Characteristics (from Table 2 - Performance Comparison):
| Item | Acceptance Criteria (implied by standards compliance) | Reported Device Performance (Subject Device K251638) | Predicate Device K220207 | Remark |
|---|---|---|---|---|
| Max. loading | Compliance with ISO 7176-8 (Static, impact and fatigue strengths) | 396.83 lbs (180kg) | 352.7lbs (160kg) | The difference will not raise any new safety and effectiveness concerns. |
| Max Speed Forwards | Compliance with ISO 7176-6:2018 (Determination of maximum speed) | 1.6 m/s (5.78 km/h) | 1.8 m/s (6.4 km/h) | The devices are evaluated according to standard ISO 7176-6:2018, so the different will not impact the safety and effectiveness. |
| Minimum braking distance | Compliance with ISO 7176-3 (Determination of effectiveness of brakes) | 1.0m for the speed of 5.78 km/h 1s | ≤1.5m for the speed of 6.4km/h 1s | The subject device complies with the requirements of ISO 7176-3. |
| Cruising Range | Compliance with ISO 7176-4 (Energy consumption for determination of theoretical distance range) | 17.5km | 20km | The difference will not raise any new safety and effectiveness concerns. |
| Slope Grade Ability | No specific standard reference provided for this item in the table, but implied by overall ISO 7176 series compliance for stability. | 14 degree | 9 degree | Larger safe operational incline of subject brings more convenient for the use environment. |
| Min. Turning radius | Addressed by ISO 7176-5 (Determination of overall dimensions, mass and manoeuvring space) | 1500mm | 1800mm | The little difference in the turning radius will not raise any new safety and effectiveness concerns. |
| Obstacle climbing | Addressed by ISO 7176-10 (Determination of obstacle-climbing ability) | 10mm | Not Publicly Available | The difference will not raise any new safety and effectiveness concerns. |
| Ground clearance | Addressed by ISO 7176-5 (Determination of overall dimensions, mass and manoeuvring space) | 63mm | 85mm | The device has been tested according to ISO7176 series standards and the test records support its safety and effectiveness. |
| Static Stability | ISO 7176-1:2014 compliant | Meets standard requirements | Meets standard requirements | Verified. |
| Dynamic Stability | ISO 7176-2:2017 compliant | Meets standard requirements | Meets standard requirements | Verified. |
| Power and Control Systems | ISO 7176-14:2008 compliant | Meets standard requirements | Meets standard requirements | Verified. |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 compliant | Meets standard requirements | Meets standard requirements | Verified. |
| Electromagnetic Compatibility | IEC 60601-1-2:2020 & IEC TR 60601-4-2 compliant | Meets standard requirements | Meets standard requirements | Verified. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the number of units tested. For physical device performance testing against standards, it's common to test a representative number of units, but this specific number is not provided in the summary.
- Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory or controlled setting, presumably as part of the manufacturer's (Suzhou Master Machinery Manufacturing Co., Ltd., China) quality assurance and regulatory submission process. There is no mention of data from human subjects or specific geographical origin for "data provenance" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device, not an AI/ML algorithm requiring expert ground truth for diagnostic or similar tasks. The "ground truth" for the device's performance is established by objective measurements against international standards.
4. Adjudication method:
- Not applicable for a physical medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This type of study is specific to AI/ML devices interacting with human interpreters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical mobility scooter, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the mobility scooter's performance is established by objective measurements and conformance to international performance, safety, and quality standards (e.g., ISO 7176 series, IEC 60601-1-2, ISO 10993 series). This is not an "expert consensus" or "pathology" in the AI/ML context.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
FDA 510(k) Clearance Letter - Mobility Scooter (MS160C)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 22, 2025
Suzhou Master Machinery Manufacturing Co., Ltd.
℅ Boyle Wang
General Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong
Shanghai, 200120
China
Re: K251638
Trade/Device Name: Mobility Scooter (MS160C)
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized Three-Wheeled Vehicle
Regulatory Class: Class II
Product Code: INI
Dated: May 29, 2025
Received: May 29, 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.
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"
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K251638 - Boyle Wang Page 2
(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-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).
Page 3
K251638 - Boyle Wang Page 3
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
Page 4
Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251638 |
|---|---|
| Please provide the device trade name(s). |
Mobility Scooter (MS160C)
| Please provide your Indications for Use below. |
|---|
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.
| Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (Part 21 CFR 801 Subpart D)☒ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
Mobility Scooter Page 12 of 67
Page 5
510(k) Summary
1 of page 7
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: Suzhou Master Machinery Manufacturing Co., Ltd.
Address: 2/F, Block B, No. 379, Delan Industrial Park, Zhangpu Town, Kunshan City, Jiangsu Province, China.
Tel: 86-512-57452882
Fax: 86-512 - 57452992
Contact: Siqi.Shangguan
Date of Preparation: Jul.10, 2025
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): MS160C
3.0 Classification
Production code: INI
Regulation number: 21 CFR 890.3800
Classification: Class II
Panel: Physical Medicine
4.0 Predicate device information
Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd.
Trade/Device: Mobility Scooter (Model: W3468)
Page 6
510(k) Summary
2 of page 7
510(k) number: K220207
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 product is a Mobility Scooter which provides transport for the disabled and the elderly and to be used both indoors and outdoors.
This scooter is a battery powered four wheeled vehicle. It consists two Lead-acid batteries (in the battery box) with an off-board battery charger, frame, a seat, a back support, control panel (including the key switch, throttle control lever, horn button, speed adjustment dial, and the battery condition meter), two foldable handles, two rear drive wheels with motor/ e-magnetic brake components, two front wheels, anti-tip devices, an external battery charger, a control panel and a motor controller. For convenience of transportation and reduction of possible damage, the battery and the seat unit can be dismantled and separately packaged.
The front wheels of the scooter are 8 inches and the rear wheels are 9 inches.
The motor of the scooter is 24VDC,150W,4200RPM; the Lead-acid Battery is 12 V, 22 Ah, 18.7 Ah; the charger is 24V/2A.
Max. loading cannot be over than 180kg.
The maximum distance travelled with a fully charged battery is 17.5km and the maximum forward speed is 1.6m/s(5.8km/h).
Braking time is less than 2 seconds, braking distance is ≤1.0 meters.
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
Page 7
510(k) Summary
3 of page 7
- 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 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
- ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC TR 60601-4-2 Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
Biocompatibility of patient-contacting parts
Patient-contacting material are carried out biocompatibility assessment in accordance with ISO 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
Table 1 - General Comparison
Page 8
510(k) Summary
4 of page 7
| Item | Subject Device K251638 | Predicate Device K220207 | 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: MS160B) | Scooter (Model: W3468) | - |
| 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 consists two Lead-acid batteries (in the battery box) with an off-board battery charger, frame, a seat, a back support, control panel (including the key switch, throttle control lever, horn button, speed adjustment dial, and the battery condition meter), two foldable handles, two rear drive wheels with motor/ e-magnetic brake components. | It has a base with Steal frame, two front wheels, two rear wheels, a seat, a tiller console, electric motor, electromagnetic brake, front light, USB charging port (Transfer power only), 2 rechargeable Lead-acid Batteries 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 | Steel | Different |
| Motor | Brushless motor, DC24V * 180W * 1 pcs | Brushless motor, 250W | Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Battery | Lead Acid DC 12 V,22 Ah, 18.7 Ah 2 pc | Lead Acid12V x 2 (22Ah) 2pc | |
| Battery charger | Off-board charger 24V/2A | Off-board charger 24V/2A |
Table 2 - Performance Comparison
| Item | Subject Device | Predicate Device K220207 | Remark |
|---|
Page 9
510(k) Summary
5 of page 7
| Item | Subject Device K251638 | Predicate Device K220207 | Remark |
|---|---|---|---|
| Dimensions (mm) | 1150x511x900 | 1075 x 510 x 930 | Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Folded dimensions (mm) | 1100x500x390 | Not Publicly Available | Minor differences in the folded dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Weight, w/ Battery | 110.2lbs. /50kg | 127.9lbs. /58kg | Both the proposed and predicate devices meet the performance testing standards ISO 7176 series. |
| Frame design | Foldable/ The electric scooter is an auxiliary walking tool powered by electricity. It can be folded after removing the battery, convenient for transport and storage. | Foldable/ The electric scooter is an auxiliary walking tool powered by electricity. It can be folded after removing the battery, convenient for transport and storage. | Same |
| Seating Design | The seat height is adjustable to suit different users, and the armrests can be adjusted in width or flipped up to facilitate getting on and off. The seat can be easily removed for folding and transportation. | The seat height is adjustable to suit different users, and the armrests can be adjusted in width or flipped up to facilitate getting on and off. The seat can be easily removed for folding and transportation. | Same |
| Folding mechanism | A foldable seat frames (The backrest could be folded to seat) | A foldable seat frames (The backrest could be folded to seat) | Same |
| Front wheel(inch) | 8 (PU tire) | 9 | Different sizes of wheel will not affect safety and performance of the subject device as all related stability tests are performed according to standard ISO 7176 series. |
| Rear tire (inch) | 9 (PU tire) | 9 | Same |
| Anti-tip Wheels (inch) | 2.5 | 2.5 | Same |
Page 10
510(k) Summary
6 of page 7
| Item | Subject Device K251638 | Predicate Device K220207 | Remark |
|---|---|---|---|
| Cruising Range(km) | 17.5 | 20km | The difference will not raise any new safety and effectiveness concerns. |
| Obstacle climbing(mm) | 10 | Not Publicly Available | The difference will not raise any new safety and effectiveness concerns. |
| Ground clearance | 63mm | 85mm | The device has been tested according to ISO7176 series standards and the test records support its safety and effectiveness. |
| Max. loading (kg) | 396.83 lbs(180kg) | 352.7lbs(160kg) | The difference will not raise any new safety and effectiveness concerns. |
| Slope Grade Ability | 14 degree | 9 degree | Larger safe operational incline of subject brings more convenient for the use environment |
| Min. Turning radium | 1500mm | 1800mm | The little difference in the turning radius will not raise any new safety and effectiveness concerns. |
| Minimum braking distance | 1.0m for the speed of 5.78 km/h 1s | ≤1.5m for the speed of 6.4km/h 1s | The subject device complies with the requirements of ISO 7176-3 |
| Max Speed Forwards | 1.6 m/s (5.78 km/h) | 1.8 m/s (6.4 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 | 0.6 m/s (2.16 km/h) | Not Publicly Available | |
| Controller | Dynamic DR50-B01 | Dynamic PG45A | Although different controller is used, both the control system, including the electromagnetic brakes and the user interface are similar. Both of the control systems are evaluated according to standard ISO7176-14:2008 and software validation requirement and there are no new safety and effectiveness concerns due to the difference. |
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510(k) Summary
7 of page 7
| Item | Subject Device K251638 | Predicate Device K220207 | Remark |
|---|---|---|---|
| Wheel Lock (type) | Electromagnetic brake | Electromagnetic brake | Same |
Table 3 - Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Materials contacting user | Hand grips: PVC; Backrest (Back support): PVC, sponge; Armrest (Arm support): PVC, sponge; Seat: PVC, sponge; Foot support pad: PEVA; Throttle controller lever: ABS. | Hand grips: PVC; Backrest (Back support): PVC, sponge; Armrest (Arm support): PVC, sponge; Seat: PVC, sponge; Foot support pad: PEVA; Throttle controller lever: ABS. | Same |
| Biocompatibility of materials contacting user | Comply with ISO 10993-1, FDA Guidance | Comply with ISO 10993-1, FDA Guidance, Tests included: Cytotoxicity (ISO 10993-5:2009), Skin Sensitization test (ISO 10993-10:2021) Intracuaneous Reacitivity Test (ISO 10993-23:2021) | Same |
Summary of substantial equivalence discussion:
Despite of the above slight 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 slight 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 K220207 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.
§ 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).