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Found 3 results
510(k) Data Aggregation
(20 days)
San Juan, Texas 78589
Re: K053192
Trade/Device Name: Series 400 Walker Regulation Number: 21 CFR 890.3825
A mechanical walker used to provide moderate weight support while walking ensuring balance and support.
Series 400 Walker
This is a premarket notification for a mechanical walker (Series 400 Walker, K053192). The document confirms that the device is substantially equivalent to legally marketed predicate devices.
The information provided does not include acceptance criteria or a study proving the device meets said criteria, because this is a mechanical walker, not an AI/Software as a Medical Device (SaMD). The information requested in the prompt is specific to SaMDs or AI-powered devices, which are evaluated differently from mechanical devices. Mechanical walkers are evaluated based on established performance standards for safety and efficacy that are typically detailed in their 510(k) submission, but not in the FDA's decision letter itself.
Therefore, I cannot provide the requested information from the given text.
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(85 days)
Myers, Florida 33912
Re: K011745
Trade/Device Name: Model HP-3 Power Wheelchair Regulation Number: 890.3825
The intended use of the HP-3 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control.
Model HP-3, Power Wheelchair
The provided document is a 510(k) clearance letter from the FDA for a power wheelchair (Model HP-3). This document does not contain the information requested for acceptance criteria and study details for a medical device's performance.
The letter simply states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory compliance and general controls, but not specific performance criteria or a study demonstrating achievement of those criteria.
Therefore, I cannot extract the requested information from this document.
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(80 days)
Myers, Florida 33912
Re: K011744
Trade/Device Name: Model HP-5, Power Wheelchair Regulation Number: 890.3825
The intended use of the HP-5 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control and also allow this chair to fold for easy transportation.
Model HP-5, Power Wheelchair
This document is a 510(k) clearance letter from the FDA for a power wheelchair, not a study describing acceptance criteria and device performance. Therefore, I cannot extract the requested information. The letter confirms substantial equivalence to a predicate device but does not detail studies or acceptance criteria for the Model HP-5.
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