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510(k) Data Aggregation
(306 days)
HEARTWAY POWER WHEELCHAIR
This device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Wheelchair, P25 is an indoor / outdoor power chair that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the power chair 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 external battery charger.
The HEARTWAY Power Wheelchair, P25 (K132856) is a powered wheelchair intended to provide mobility to persons restricted to a seated position. The device's performance was evaluated against a series of ISO 7176 standards related to wheelchairs and other relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Standard / Criteria | Acceptance Criteria (Implicit from Compliance) | Reported Device Performance (Implicit from Compliance) |
|---|---|---|
| EMC Report (ANSI / RESNA WC/Vol.2: 2009, CISPR 11: 2004+A2:2006, EN61000-4-2: 2008, IEC61000-4-3: 2006, IEC61000-4-8: 2001) | Compliance with Electromagnetics Compatibility requirements | Compliant (Reported as completed) |
| ISO 7176-1 (Static stability) | Compliance with static stability requirements | Compliant (Reported as completed) |
| ISO 7176-2 (Dynamic stability) | Compliance with dynamic stability requirements | Compliant (Reported as completed) |
| ISO 7176-3 (Brake effectiveness) | Compliance with brake effectiveness requirements | Compliant (Reported as completed) |
| ISO 7176-4 (Energy consumption/theoretical distance range) | Compliance with energy consumption requirements | Compliant (Reported as completed) |
| ISO 7176-5 (Overall dimensions, mass, maneuvering space) | Compliance with dimensional, mass, and maneuvering space requirements | Compliant (Reported as completed) |
| ISO 7176-6 (Max speed, acceleration, deceleration) | Compliance with speed, acceleration, and deceleration limits | Compliant (Reported as completed) |
| ISO 7176-7 (Seating dimensions) | Compliance with seating dimension definitions and measurement methods | Compliant (Reported as completed) |
| ISO 7176-8 (Static, impact, and fatigue strength) | Compliance with strength requirements | Compliant (Reported as completed) |
| ISO 7176-9 (Climatic tests) | Compliance with climatic test requirements | Compliant (Reported as completed) |
| ISO 7176-10 (Obstacle-climbing ability) | Compliance with obstacle-climbing ability requirements | Compliant (Reported as completed) |
| ISO 7176-11 (Test dummies) | Compliance with test dummy specifications | Compliant (Reported as completed) |
| ISO 7176-13 (Coefficient of friction of test surfaces) | Compliance with coefficient of friction standards | Compliant (Reported as completed) |
| ISO 7176-14 (Power and control system) | Compliance with power and control system requirements | Compliant (Reported as completed) |
| ISO 7176-15 (Information disclosure, documentation, labeling) | Compliance with information, documentation, and labeling requirements | Compliant (Reported as completed) |
| ISO 7176-16 (Resistance to ignition of upholstered parts) | Compliance with ignition resistance requirements | Compliant (Reported as completed) |
| ISO 7176-21 (EMC of powered wheelchairs and scooters) | Compliance with electromagnetic compatibility requirements | Compliant (Reported as completed) |
| UL Certification (for electronic systems) | Compliance with UL safety standards | Compliant (P&G VR2 controller, batteries, recharger, switches, power supplies are UL certified) |
| Maximum Weight Bearing Capacity | 120 kgs / 265 lbs | 120 kgs / 265 lbs (stated as a specification) |
| Incline Capability | Over 10 degrees (recommended not to operate on slopes over 10 degrees, implying capability for up to 10 degrees) | 10 degrees (same as predicate device) |
| Turning Radius | 650 mm / 25.6" | 650 mm / 25.6" (stated as a specification) |
| Ground Clearance | 80 mm / 3.2" | 80 mm / 3.2" (stated as a specification) |
| Curb Climbing Ability | 75 mm / 3.0" | 75 mm / 3.0" (stated as a specification) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for performance testing of the device itself (P25). It does mention various ISO and other standards that the device complies with, implying that testing was conducted according to the methodologies defined by these standards. The data provenance is Taiwan, R.O.C., where the manufacturer is located. The nature of these tests (e.g., laboratory simulations, physical trials) is characteristic of prospective performance evaluations during product development and regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information (number and qualifications of experts) is not typically detailed for performance testing of a medical device like a powered wheelchair, as the ground truth is established by objective measurements and adherence to engineering standards. The compliance with ISO and other recognized standards serves as the basis for "ground truth" concerning the device's physical and electrical performance.
4. Adjudication Method for the Test Set:
Not applicable for this type of performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where subjective interpretation is involved. For this device, compliance is determined by objective measurements against established standard criteria.
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:
Not applicable. This is not an AI-assisted diagnostic or interpretive device, but rather a mobility device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, and its performance is evaluated through standardized physical and electrical tests.
7. The Type of Ground Truth Used:
The ground truth is established by adherence to internationally recognized engineering and safety standards (e.g., ISO 7176 series, CISPR, EN, IEC, ANSI/RESNA WC/Vol.2) and UL certifications. These standards define objective performance criteria and test methods for powered wheelchairs.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI-driven device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reason as above.
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(53 days)
IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7
The intended use of the HP-7 provide mobility to adults limited to thing position that have the to operates a simple han Capa
Model HP-7 Power Wheelchair
The provided text is a 510(k) Premarket Notification letter from the FDA concerning a power wheelchair (Model HP-7). This type of document does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or detailed performance data for the device.
The FDA 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific performance criteria through a detailed clinical study in the way typically seen for novel medical devices or AI algorithms.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from the provided text. The letter only confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to a predicate device.
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