Hoveround Teknique GT Power Wheelchair, Model# Teknique GT
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100350 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 device is a powered wheelchair, specifically a rear-wheel drive power chair designed for active users. It combines sturdy design and custom-contoured seating with additional power for enhanced outdoor maneuverability and riding performance.
It is supplied as a reusable device intended for use in personal mobility settings. The device received FDA 510(k) clearance (K100350) and is classified as a Class II medical device under regulation number 890.3860, with product code ITI and advisory committee designation in Physical Medicine.
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: PDF teknique Gt For active users - hoveround.com, Hoveround Teknique GT Manuals | ManualsLib, PDF TEKNIQUE® - Hoveround, Teknique GT Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100350 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hoveround Corp.
Sources (1)
- FDA 510(k) K100350 24 fields · synced Sep 25, 2026