Identifiers
- 510(k) Number
- K172384 FDA 510(k)
- FDA Product Code
- IPL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3900 FDA 510(k)
- Regulation Number
- 890.3900 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quickie Q700-UP M is a Stand-Up Power Wheelchair (OpenFDA classification: IPL, Device Class II), designed to assist individuals with mobility impairments in transitioning between seated and standing positions. It incorporates a mid-wheel drive base and a biomechanical seating system to enhance user stability, comfort, and functional independence during transfers and weight-bearing activities.
This device is supplied as a reusable, non-sterile medical product intended for use in home, clinical, and community settings. It is regulated under FDA 510(k) clearance (K172384) and EU MDR compliance, with a primary application in Physical Medicine as defined by OpenFDA. The wheelchair is available in a single model configuration (Q700-UP M) and requires proper maintenance per manufacturer guidelines. No MRI safety classification or additional sterilisation is specified.
Frequently asked questions
What types of environments is the Quickie Q700-UP M wheelchair designed for use in?
The Quickie Q700-UP M is intended for use in multiple settings, including homes, clinical environments, and community spaces. Its design supports mobility assistance for individuals with impairments, making it suitable for both personal and professional use where stability and functional independence are priorities.
Is the Quickie Q700-UP M wheelchair reusable or single-use, and does it require sterilization?
The Quickie Q700-UP M is a reusable, non-sterile medical device. It is not intended for sterilization and should be maintained according to the manufacturer’s guidelines to ensure safe and effective use over time.
How many model variations of the Quickie Q700-UP M are available, and what distinguishes them?
The Quickie Q700-UP M is available in a single model configuration, labeled as Q700-UP M. It features a mid-wheel drive base and a biomechanical seating system to enhance stability and comfort during transfers and weight-bearing activities, but no additional model variations are specified.
What regulatory pathways does the Quickie Q700-UP M follow, and where is it manufactured?
The Quickie Q700-UP M is regulated under FDA 510(k) clearance (K172384) and complies with EU MDR requirements. It is manufactured by Sunrise Medical (US) LLC, based in Fresno, California, USA.
What maintenance is required for the Quickie Q700-UP M, and is it safe for use in an MRI environment?
The Quickie Q700-UP M requires proper maintenance as outlined by the manufacturer to ensure safe and reliable operation. However, there is no specified MRI safety classification for this device, meaning it should not be used in an MRI environment unless explicitly approved for such use by the manufacturer.
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: QUICKIE Q700-UP M Standing Power Wheelchair | Sunrise Medical, QUICKIE Q700 M Power Wheelchair | Sunrise Medical, Sunrise Medical Quickie Q700-UP M Owner's Manual, Sunrise Medical Quickie Q700-UP M Instructions For Use Manual, QUICKIE Q700-UP M Standing Power Wheelchair | Sunrise Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K172384 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
- FDA Applicant
- Sunrise Medical (Us), LLC
Sources (2)
- FDA 510(k) K172384 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026