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510(k) Data Aggregation
(169 days)
The device 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 subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The NXN20-208 and NXN20-211 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.
The Powered Wheelchair has 7 inch front wheel and 11 inch rear tire.
The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A.
Max. loading can not be over than 110Kgs.
Max. distance of travel on the fully charged battery is 16 km and Max. speed forward is 6km/h.
The braking time is about 2s, and the braking distance is
The provided document is a 510(k) premarket notification for a Powered Wheelchair (models NXN20-208, NXN20-211). It focuses on demonstrating substantial equivalence to a predicate device (A08 Power Wheelchair, K163204) rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding clinical studies, ground truth establishment, expert adjudication, and AI performance is not applicable to this submission.
However, the document does contain "acceptance criteria" through a demonstration of compliance with recognized standards and a comparison of performance characteristics to a predicate device, which serves as a benchmark for safety and effectiveness in this regulatory context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance
For a medical device like a powered wheelchair, acceptance criteria are generally defined by compliance with a set of established performance standards. The "reported device performance" is demonstrated by the completion of non-clinical tests verifying compliance with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance Status) |
|---|---|
| ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability | Complies |
| ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs | Complies |
| ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes | Complies |
| ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Complies |
| ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space | Complies |
| ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Complies |
| ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions | Complies |
| ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strengths | Complies |
| ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs | Complies |
| ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Complies |
| ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies | Complies |
| ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces | Complies |
| ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | Complies |
| ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling | Complies |
| ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers | Complies |
| ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures | Complies |
| ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs | Complies |
| ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method | Complies |
| IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | Complies |
| Software Verification and Validation Testing (according to FDA Guidance) | Complies |
| Biocompatibility of materials contacting user (Comply with FDA Guidance) | Complies |
Performance Characteristics (Comparison with Predicate Device):
| Item | Proposed Device | Predicate Device | Acceptance (Remark) |
|---|---|---|---|
| Overall length | NXN20-208: 1000mm; NXN20-211: 950mm | 890 mm | Minor differences will not impact safety and effectiveness. |
| Overall width | 600mm | 603 mm | Minor differences will not impact safety and effectiveness. |
| Stowage length | 340mm | 324 mm | Minor differences will not impact safety and effectiveness. |
| Stowage width | 600mm | 603 mm | Minor differences will not impact safety and effectiveness. |
| Stowage height | NXN20-208: 775mm; NXN20-211: 765mm | 670 mm | Minor differences will not impact safety and effectiveness. |
| Weight, w/ Battery | NXN20-208: 42.99 lbs./19.5kg; NXN20-211: 36.48 lbs./16.55kg | 61.7 lbs. /28 kg | The difference will not raise any new safety and effectiveness concerns. |
| Front wheel (inch) | 7 (PU solid tire) | 8 (PU solid tire) | Smaller sizes of front wheels. |
| Rear tire (inch) | 11 (PU solid tire) | 10 (PU solid tire) | Larger sizes of rear wheels bring steadier pivoting function than the predicate device. |
| Cruising Range (km) | 16 | 20 | The subject device complies with ISO 7176-4:2008 for energy consumption; these differences do not affect safety and effectiveness. |
| Obstacle climbing (mm) | 25 | 40 | The smaller height in the obstacle climbing will not impact the safety and effectiveness of the subject device. |
| Static stability forward | 18.8° | Not publicly available | Both devices evaluated per ISO 7176-1:2014; different static stability will not impact safety and effectiveness. |
| Static stability rearward | 20.4° | Not publicly available | Both devices evaluated per ISO 7176-1:2014; different static stability will not impact safety and effectiveness. |
| Static stability sideways | 20.5° | Not publicly available | Both devices evaluated per ISO 7176-1:2014; different static stability will not impact safety and effectiveness. |
| Max. loading (kg) | 242.5lbs (110kg) | 220 lbs (100 kg) | More loading weight means more convenient for transportation. |
| Min. Turning radium | NXN20-208: 850mm; NXN20-211: 840mm | 800mm | Similar |
| Minimum braking distance |
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