510(k) K251565

Wheelchair (N817) by Zhejiang Topwe Tools Manufacturing Co.,Ltd — Product Code ITI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 6, 2025
Date Received: May 22, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Wheelchair, Powered
Device Class: Class II
Regulation Number: 890.3860
Review Panel: PM
Submission Type

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

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