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Electric Wheelchair Model P2

by Superpi Robot Co., Ltd.

510(k) K252428

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252428↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252428 Date18 Sep 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
ITI
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Electric Wheelchair Model P2 is a powered mobility device designed for individuals requiring assistance with ambulation. Classified as a Class II medical device, it is intended to provide independent mobility for users in various environments, including indoor and outdoor settings.

This device is supplied as a reusable, non-sterile product and is intended for use in clinical and home settings. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with a weight of 45 lbs, making it lightweight and portable. The Model P2 is manufactured by Superpi Robot Co., Ltd., and its regulatory classification aligns with the International Classification for Medical Devices (ICD) code ITI.

Other devices from Superpi Robot Co., Ltd.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What environments is the Electric Wheelchair Model P2 designed to operate in and how does its lightweight design benefit users?

    The Electric Wheelchair Model P2 is specifically designed for use in both indoor and outdoor environments, providing mobility assistance in various settings. Its lightweight construction at 45 lbs makes it highly portable, allowing users to easily transport it between locations, such as from home to clinical settings or across different rooms within a facility.

  • Is the Electric Wheelchair Model P2 intended for single-use or reusable applications, and what does this mean for maintenance?

    The Electric Wheelchair Model P2 is supplied as a reusable device, meaning it is not intended for single-use. This classification implies that it requires regular cleaning, maintenance, and inspection to ensure safe and effective operation over time. Users should follow manufacturer guidelines for upkeep to prolong its lifespan and functionality.

  • What regulatory pathways has the Electric Wheelchair Model P2 followed, and how does this impact its availability?

    The Electric Wheelchair Model P2 has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). These regulatory pathways confirm its safety and performance standards, ensuring it meets the necessary requirements for distribution in the United States and European markets. The device’s classification as Class II further supports its regulatory compliance and availability for clinical and home use.

  • How does the manufacturer, Superpi Robot Co., Ltd., support users or facilities in maintaining or servicing the Electric Wheelchair Model P2?

    While the provided data does not specify direct maintenance support details, Superpi Robot Co., Ltd. is based in Hangzhou, China, and can be contacted through their listed address (Rm. N901, 9th Floor, Yungu Fudi Center, #181 Jingda Rd., Hangzhou, 310030) or via contact person Xuan Li. Users or facilities should refer to the manufacturer’s documentation or reach out for guidance on maintenance, servicing, or warranty information to ensure proper upkeep of the device.

  • What does the product code ITI indicate about the regulatory classification or intended use of the Electric Wheelchair Model P2?

    The product code ITI aligns with the International Classification for Medical Devices (ICD) and categorizes the Electric Wheelchair Model P2 under the ‘Physical Medicine’ specialty. This classification reflects its intended use for individuals requiring mobility assistance, particularly in clinical and home settings, rather than defining a specific medical condition or procedure. It is an administrative code used for regulatory filing purposes.