Tacahe PC1350 Power Wheelchair
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080373 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 PC1350 Power Wheelchair is a powered wheelchair designed to provide mobility for individuals with limited physical ability to walk. It is a mid-wheel drive power chair with a weight capacity of 350 lbs, offering enhanced maneuverability and comfort for users seeking a stable and efficient mobility solution.
The device operates via a user-controlled interface allowing navigation in indoor and outdoor environments. It is supplied as a finished device and has received FDA 510(k) clearance under K080373, with a device classification of Class II and product code ITI. The device is intended for use in accordance with its cleared indications and is not described as sterile, single-use, or MRI safe in the provided data.
Frequently asked questions
What is the Tacahe PC1350 Power Wheelchair intended for?
The Tacahe PC1350 Power Wheelchair is designed to provide mobility for individuals with limited physical ability to walk, enabling navigation in both indoor and outdoor environments through a user-controlled interface.
How is the Tacahe PC1350 Power Wheelchair supplied and what is its weight capacity?
The device is supplied as a finished power wheelchair and has a weight capacity of 350 lbs, offering enhanced maneuverability and comfort for users seeking a stable mobility solution.
Is the Tacahe PC1350 Power Wheelchair sterile or single-use?
The device is not described as sterile or single-use in the provided data; it is a reusable powered wheelchair intended for repeated use by an individual over time.
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: Dalton Medical - Tacahe - Pc1350-Ar - Mid - Wheel Drive 350 Lbs Wt ..., Power wheelchairs - Dalton Medical: Reliable Medical Products ..., TACAHE PC1350 POWER WHEELCHAIR (K080373) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080373 | Class II | Active |
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Manufacturer
- Manufacturer
- Dalton Medical Corp.
Sources (1)
- FDA 510(k) K080373 24 fields · synced Sep 21, 2026