Home / 510(k) Clearances / K251891

510(k) K251891

Electric Wheelchair (GY-E001) by Shandong Guyue Healthcare Appliance Co., Ltd. — Product Code ITI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2025
Date Received
June 20, 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)