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Tacahe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052534

by Dalton Medical Corp.

Identifiers

510(k) Number
K052534 FDA 510(k)
FDA Product Code
ITI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.3860 FDA 510(k)
Regulation Number
890.3860 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tacahe Mid-Wheel Drive Powerchair is a motorised wheelchair designed for mobility assistance. Classified as a Powered Wheelchair under the FDA’s nomenclature, it is intended for individuals requiring powered mobility support, providing enhanced manoeuvrability and stability through its mid-wheel drive configuration. This design reduces the risk of tipping and improves navigation in tight spaces, making it suitable for both indoor and outdoor use. The device is engineered to accommodate users with varying mobility needs, including those with limited upper-body strength or limited mobility in their arms and legs.

The Tacahe Mid-Wheel Drive Powerchair is supplied as a reusable medical device, intended for long-term patient use. It is not sterile at the time of delivery but may be cleaned and maintained according to manufacturer guidelines for continued safe operation. The device is classified as Class 2 under FDA regulations (regulation number 890.3860) and has been cleared through the Traditional 510(k) pathway (K052534). It is designed for users with a weight limit of up to 350 lbs and is intended for use in clinical and home settings. No specific MRI safety information is provided in the available data.

Frequently asked questions

What is the Tacahe Mid-Wheel Drive Powerchair designed for?

The Tacahe Mid-Wheel Drive Powerchair is specifically designed for individuals requiring powered mobility assistance. Its mid-wheel drive configuration enhances manoeuvrability and reduces the risk of tipping, making it suitable for users with limited upper-body strength or restricted arm/leg mobility. This design is particularly beneficial for navigating tight spaces, both indoors and outdoors.

Is the Tacahe Powerchair reusable or single-use?

The Tacahe Mid-Wheel Drive Powerchair is a reusable medical device. It is intended for long-term patient use and can be cleaned and maintained according to the manufacturer’s guidelines to ensure continued safe operation. Unlike single-use devices, it is not sterile at the time of delivery.

What is the weight capacity of the Tacahe Mid-Wheel Drive Powerchair?

The Tacahe Mid-Wheel Drive Powerchair is engineered to accommodate users with a maximum weight limit of 350 lbs. This ensures it can safely support a broad range of individuals requiring powered mobility assistance in both clinical and home settings.

How is the Tacahe Powerchair classified under FDA regulations?

The Tacahe Mid-Wheel Drive Powerchair is classified as a Class 2 device under FDA regulations, specifically under regulation number 890.3860. This classification reflects its moderate risk level, requiring special controls to ensure its safety and effectiveness for powered mobility support.

Does the Tacahe Powerchair have any specific MRI safety information?

The available data for the Tacahe Mid-Wheel Drive Powerchair does not provide any specific MRI safety information. Users should consult the manufacturer’s guidelines or contact Dalton Medical Corp. for detailed instructions if MRI compatibility is a concern, as some components may pose risks in magnetic environments.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K052534 FDA 510 (k) - TACAHE | Dalton Medical Corp., Dalton Medical: Reliable Medical Products | Equipment | Supplies | Devices, Dalton Medical Corporation Pc1350-bl Dalton Tacahe Mid-wheel Drive ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dalton Medical Corp.

Sources (1)

  • FDA 510(k) K052534 24 fields · synced Oct 1, 2026