(21 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S Powered Wheelchair MAMBO 36X is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armirests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembly d for transport and is provided with an onboard battery charger.
This document describes a 510(k) premarket notification for a powered wheelchair, the WU'S POWERED WHEELCHAIR, MAMBO 36X (later changed to FORYOU POWER WHEELCHAIR, FC-100). The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study.
Therefore, many of the requested categories related to acceptance criteria, ground truth, expert review, and sample sizes for a performance study are not directly applicable or available in this type of submission. The "study" mentioned is a comparison to a legally marketed device to establish substantial equivalence.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This type of information is not typically presented for a 510(k) submission showing substantial equivalence for a powered wheelchair. The "acceptance criteria" here are generally compliance with relevant standards and demonstrating equivalence in key performance characteristics to a predicate device, rather than quantitative performance targets.
| Acceptance Criteria Category | Reported Device Performance (or Equivalence Claim) |
|---|---|
| Intended Use | "To provide mobility to persons restricted to a seated position." (Claimed same as predicate device) |
| Mainframe Foldability | Foldable (Claimed same as predicate device) |
| Mainframe Materials | Meet strength and fatigue tests; similar materials (Claimed same as predicate device) |
| Cross Brace Suspension | Same as predicate device |
| Armrest Type | Same as predicate device |
| Back Upholstery Material | Same fabric as predicate device --------------------------------------------- |
| Electronic Systems | Same suppliers as predicate device, all UL certified for safety (controller, batteries, charger). |
| EMC/Electrical Safety | Compliant with ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No "test set" in the sense of patient data or clinical images was used. The substantial equivalence was based on a comparison of device specifications, materials, and compliance with performance standards.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. No ground truth based on expert review was established for this submission. The "ground truth" for substantial equivalence is the predicate device's characteristics and its prior clearance.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This is a medical device clearance based on substantial equivalence, not an AI efficacy study.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No. This device is a physical product (powered wheelchair), not an algorithm. Performance refers to mechanical and electrical safety standards compliance.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this 510(k) submission is the characteristics and performance of the legally marketed predicate device (TEH LIN JUPITER Powered Wheelchair TL-320 (K022697)) and compliance with relevant performance standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995).
8. Sample Size for the Training Set
- Sample Size: Not applicable. There is no AI model or "training set" for a powered wheelchair.
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).