(20 days)
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.
§ 890.3825 Mechanical walker.
(a)
Identification. A mechanical walker is a four-legged device with a metal frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.