(62 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The COMFORT SCOOTER, LY-EW406 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The Comfort Scooter, LY-EW406, is a motorized three-wheeled vehicle intended for medical purposes to provide mobility to persons restricted to a seated position.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate Device K022369) | Reported Device Performance (LY-EW406) |
|---|---|---|
| Permissible Load Weight | 265 lbs | 265 lbs |
| Electronic Controller | UL Certified | UL Certified |
| Recharge System | UL Certified | UL Certified |
| Electrical Safety | ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 standards for electrically powered wheelchairs, controllers, and chargers | Compliant with ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 |
| Max Speed | 4.0 mph (predicate) | 4.2 mph |
| Intended Use | To provide mobility to persons restricted to a seated position | To provide mobility to persons restricted to a seated position |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not detail a "test set" in the context of clinical data or comparative performance against a predefined set of cases/patients. The performance testing referenced is against engineering standards and comparison to a predicate device.
Data provenance: Taiwan, R.O.C. (Manufacturer location). The nature of the testing suggests it is primarily engineering/bench testing rather than clinical data, therefore it would be considered prospective for the device under test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study does not involve human expert interpretation of data for ground truth establishment. The "ground truth" for this device's performance is compliance with established electrical and wheelchair performance standards, and comparison of specifications to a legally marketed predicate device.
4. Adjudication Method for the Test Set
Not applicable. This type of adjudication method is usually for clinical studies with expert reviewers, which is not relevant for this device's submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices involving human interpretation of medical images or data. The Comfort Scooter is a mobility device; its performance is evaluated against engineering standards and functional specifications rather than clinical diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (electric scooter), not an algorithm or AI system. Its performance evaluation is based on direct measurements and adherence to specified standards.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on:
- Engineering Standards: Compliance with recognized international and national standards for electrically powered wheelchairs and electrical safety (e.g., ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3).
- Predicate Device Specifications: Direct comparison of key performance characteristics (e.g., load capacity, controller type, recharge system, maximum speed) to a legally marketed device (COMFORT AGILE SCOOTER LY-EW303, K022369) to establish substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no training set in the context of machine learning or AI for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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).