Identifiers
- 510(k) Number
- K001970 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 Jet 1 Powered Wheelchair is a motorised mobility device designed for individuals requiring electric propulsion. Classified as a Powered Wheelchair under FDA nomenclature, it is intended to assist users in indoor and outdoor environments by providing controlled movement via electric motors and joystick controls. This device is engineered to enhance independence and mobility for those with limited ambulatory capacity.
This wheelchair is supplied as a reusable, non-sterile medical device, intended for home or clinical use. It is regulated under FDA 510(k) clearance (K001970) and falls under Class II medical devices (regulation number 890.3860). The Jet 1 is manufactured by Pride Mobility Products Corp. and is equipped for standard indoor and outdoor settings, with no specific MRI safety restrictions noted. No information regarding single-use or sterilisation is provided, and sizes or storage requirements are not detailed in the regulatory data.
Frequently asked questions
What is the Jet 1 Powered Wheelchair used for?
The Jet 1 Powered Wheelchair is designed to assist individuals with limited mobility by providing electric propulsion for controlled movement. It is intended for use in both indoor and outdoor environments, helping users achieve greater independence and freedom of movement.
Is the Jet 1 Powered Wheelchair reusable or single-use?
The Jet 1 Powered Wheelchair is supplied as a reusable device. It is not intended for single-use or sterilization, making it suitable for long-term use in home or clinical settings.
What regulatory approval does the Jet 1 Powered Wheelchair hold?
The Jet 1 Powered Wheelchair holds FDA 510(k) clearance under the classification of a Class II medical device, regulated under the FDA’s regulation number 890.3860. This clearance confirms its substantial equivalence to a predicate device and ensures it meets applicable safety and performance standards.
Are there any specific safety restrictions for the Jet 1 Powered Wheelchair?
The Jet 1 Powered Wheelchair does not have any noted MRI safety restrictions. However, as with all powered mobility devices, users should follow standard safety guidelines for operation in various environments to ensure safe and effective use.
What types of environments is the Jet 1 Powered Wheelchair suitable for?
The Jet 1 Powered Wheelchair is engineered for standard indoor and outdoor settings. Its design supports controlled movement in both home and clinical environments, making it versatile for daily use.
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: PRIDE MOBILITY JET 1 OWNER'S MANUAL Pdf Download, PRIDE MOBILITY JET1 OWNER'S MANUAL Pdf Download, Pride Mobility JET1 Owner`s manual - ManualZilla, Pride Mobility JET1 : Owner`s manual - ManualShelf, PRIDE MOBILITY JET 1 OWNER'S MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001970 | Class II | Active |
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Manufacturer
- Manufacturer
- Pride Mobility Products Corp.
Sources (1)
- FDA 510(k) K001970 24 fields · synced Oct 1, 2026