(58 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 Mobility Scooter, Models W3468, has a base with Steal frame, two front wheels, a seat, a tiller console, electromagnetic brake, front light, USB charging port (Transfer power only), 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.
The document is a 510(k) Summary for a Mobility Scooter (Model: W3468). It describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device (K182471).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Mobility Scooter (Model: W3468) are based on demonstrating compliance with a series of ISO 7176 standards. The reported device performance indicates that the device met these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Reference to Standard Compliance) |
|---|---|
| Biocompatibility | All user directly contacting materials are compliant with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) requirements. |
| EMC (Electromagnetic Compatibility) | ISO 7176-21: The EMC performance results meet the requirements of ISO 7176-21. |
| Performance (ISO 7176 Series) | ISO 7176-1 (Static Stability): The static stability has been determined after testing according to ISO 7176-1, and test results meet its design specification. |
| ISO 7176-2 (Dynamic Stability): The dynamic stability has been determined after testing according to ISO 7176-2, and test results meet its design specification. | |
| ISO 7176-3 (Effectiveness of Brakes): The effectiveness of brakes has been determined after testing according to ISO 7176-3, and test results meet its design specification. | |
| ISO 7176-4 (Energy Consumption/Theoretical Distance Range): The theoretical distance range has been determined after testing according to ISO 7176-4, and test results meet its design specification. | |
| ISO 7176-5 (Overall Dimensions, Mass, and Maneuvering Space): The dimensions, mass has been determined after testing according to ISO 7176-5. | |
| ISO 7176-6 (Maximum Speed, Acceleration, and Deceleration): The dimensions, mass has been determined after testing according to ISO 7176-5 (Note: This might be a typo in the document repeatedly referencing 7176-5 for two separate sections; it should likely reference 7176-6 for speed, acceleration, and deceleration). | |
| ISO 7176-7 (Seating and Wheel Dimensions): The seating and wheel dimensions have been determined after testing according to ISO 7176-7. | |
| ISO 7176-8 (Static, Impact, and Fatigue Strengths): All test results meet the requirements in Clause 4 of ISO 7176-8. | |
| ISO 7176-9 (Climatic Tests): The test results showed that the device under test could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9. | |
| ISO 7176-10 (Obstacle-climbing Ability): The obstacle-climbing ability of the device has been determined after testing according to ISO 7176-10. | |
| ISO 7176-11 (Test Dummies): The test dummies used in the testing of ISO 7176 series meet the requirements of ISO 7176-11. | |
| ISO 7176-13 (Coefficient of Friction of Test Surfaces): The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved. | |
| ISO 7176-14 (Power and Control Systems): All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. | |
| ISO 7176-15 (Information Disclosure, Documentation, and Labeling): The test results showed that information disclosure, documentation, and labeling of device meet the requirements of ISO 7176-15. | |
| ISO 7176-16 (Resistance to Ignition of Postural Support Devices): The performance of resistance to ignition met the requirements of ISO 7176-16. | |
| ISO 7176-25 (Batteries and Chargers): The performance of batteries and charger of device met the requirements in Clause 5 and 6 of ISO 7176-25. | |
| Label and labeling | Conforms to FDA Regulatory. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size used for the test set" in terms of number of devices. Non-clinical tests were conducted on the "proposed device" (Mobility Scooter, Model W3468).
The provenance of the data is from non-clinical testing performed by the manufacturer, Zhejiang Innuovo Rehabilitation Devices Co., Ltd, in China. This is a prospective testing approach conducted specifically for this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of submission. The "ground truth" for the non-clinical tests is established by the specifications and criteria outlined in the referenced ISO standards. The tests are typically performed by qualified engineers or technicians in a testing facility. The document does not specify the number or qualifications of these individuals, but generally, such testing requires expertise in the relevant engineering and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. The non-clinical tests against ISO standards usually involve objective measurements and comparisons against predefined thresholds, rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a non-clinical 510(k) submission for a physical medical device (mobility scooter) and does not involve AI or human readers for diagnostic interpretation.
6. Standalone (Algorithm Only) Performance Study
No. This is a non-clinical 510(k) submission for a physical medical device (mobility scooter) and does not involve an algorithm.
7. Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on the objective, measurable requirements and specifications defined by the international standards of the ISO 7176 series, ISO 10993 series, and FDA regulations for labeling.
8. Sample Size for the Training Set
Not applicable. This is a non-clinical 510(k) submission for a physical medical device and does not involve AI or machine learning models that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
§ 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).