UPnRIDE Wheelchair, Standup

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

No FDA recalls on record, checked 6 Oct 2026.

Full name

UPnRIDE

Device Name

UPnRIDE

Model / Reference

UpnRIDE

FDA applicant

Upnride Robotics , Ltd.

Primary DI / UDI-DI

07290016792010

Basic UDI-DI

7290019197UPnRIDE9F

Direct Marketing DI

07290016792010

510(k) Number

K182257 ↗

FDA Product Code

IPL

EMDN Code

Y122127 Electric wheelchairs

Device Class

Class I EUDAMED

Class II 510(k)

Regulation

21 CFR Part 890.3900

Market of Registration

Netherlands

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• What types of clinical settings is the UPnRIDE Wheelchair, Standup designed for and how does it differ from traditional wheelchairs?

  The UPnRIDE Wheelchair, Standup is specifically designed for rehabilitation environments within physical medicine settings, where users require assistance transitioning between seated and upright positions. Unlike traditional wheelchairs, it integrates self-balancing robotic technology to actively support standing and seated mobility, making it ideal for users with physical limitations who benefit from dynamic positioning. This distinguishes it from standard wheelchairs, which lack active robotic assistance for standing.

• Is the UPnRIDE Wheelchair, Standup intended for single-use or reusable applications, and what does this mean for maintenance?

  The UPnRIDE is reusable and non-sterile, meaning it is built for repeated clinical use in controlled environments like rehabilitation centers. Since it is not single-use, proper maintenance and cleaning protocols—as outlined by the manufacturer—must be followed to ensure functionality, safety, and compliance with regulatory standards (e.g., 21 CFR 890.3900). This also implies it requires periodic inspections and servicing to maintain performance.

• How is the UPnRIDE Wheelchair, Standup regulated, and what does its FDA 510(k) clearance (K182257) indicate about its approval process?

  The UPnRIDE is regulated as a Class II medical device under FDA guidelines and holds a 510(k) clearance (K182257), which means it was determined to be substantially equivalent to a legally marketed predicate device through a traditional review process. This clearance confirms the device meets FDA safety and effectiveness requirements for its intended use in physical medicine settings, though it does not imply approval for any specific clinical indication beyond its described functionality. Compliance also extends to EU MDR standards, though no third-party certification is required.

• What storage requirements should be followed for the UPnRIDE Wheelchair, Standup to ensure optimal performance and longevity?

  The UPnRIDE must be stored according to the manufacturer’s guidelines to preserve functionality and safety. While the data does not specify exact storage conditions (e.g., temperature, humidity), typical robotic medical devices require protection from physical damage, moisture, and extreme environments. Since it is reusable and non-sterile, storage areas should be clean, dry, and free from contaminants to prevent wear or malfunctions. Adhering to these protocols ensures compliance with regulatory expectations and maintains the device’s operational integrity.