510(k) K252428

Electric Wheelchair (Model P2) by Superpi Robot Co., Ltd. — Product Code ITI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 18, 2025
Date Received: August 1, 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).

Other clearances for product code ITI

K253870 — Electric Wheelchair (MP148) (March 4, 2026)
K253789 — Electric wheelchair (February 25, 2026)
K253707 — Electric wheelchair (W1,W3) (February 24, 2026)
K253599 — Electric Wheelchair (W-A807, W-A807L) (February 17, 2026)
K253276 — Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E (January 15, 2026)
K251458 — Electric Wheelchair (DH01168) (January 15, 2026)
K251159 — Power wheelchair (December 22, 2025)
K252862 — Electric Wheelchair (DH01126) (December 8, 2025)
K252494 — Electrically powered wheelchair (KZ301B) (December 5, 2025)
K252829 — Powered Wheelchair (PL001-9001) (November 12, 2025)