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Power Wheelchair (ZS-EW8026)

by Ningbo Zhishan Medical Technology Co., Ltd

510(k) K254206

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK254206 Date27 Mar 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ITI
FDA applicant
Ningbo Zhishan Medical Technology Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Power Wheelchair (ZS-EW8026) is a Class II medical device designed to provide mobility assistance for individuals with limited mobility. It is a powered wheelchair that operates through electric motors, allowing users to navigate various environments independently.

This device is manufactured by Ningbo Zhishan Medical Technology Co., Ltd. and is authorized under FDA 510K clearance with K-number K254206. It is classified under product code ITI and is intended for use in physical medicine applications. The device is supplied in various sizes as indicated by the model number ZS-EW8026.

Other devices from Ningbo Zhishan Medical Technology Co., Ltd

Questions

AI-generated answers, 23 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 is the Power Wheelchair ZS-EW8026 designed for?

    The Power Wheelchair ZS-EW8026 is a Class II medical device designed to provide mobility assistance for individuals with limited mobility, allowing users to navigate various environments independently through its electric motor operation.

  • How is the Power Wheelchair ZS-EW8026 supplied?

    The device is manufactured by Ningbo Zhishan Medical Technology Co., Ltd. and is supplied in various sizes as indicated by the model number ZS-EW8026, with different configurations available to meet individual user needs.

  • What is the regulatory status of the Power Wheelchair ZS-EW8026?

    The Power Wheelchair ZS-EW8026 has received FDA 510K clearance with K-number K254206, classified under product code ITI, and is intended for use in physical medicine applications as determined by the review advisory committee.

  • Can the Power Wheelchair ZS-EW8026 be used in different environments?

    Yes, the Power Wheelchair ZS-EW8026 is designed to allow users to navigate various environments independently, making it suitable for both indoor and outdoor use depending on the specific model configuration and user requirements.