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510(k) K231750

MA012 Aluminum wheelchair, MS019 steel wheelchair by Sichuan Ast Medical Equipment Co., Ltd. — Product Code IOR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2023
Date Received
June 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Mechanical
Device Class
Class I
Regulation Number
890.3850
Review Panel
PM
Submission Type

A mechanical wheelchair is a manually 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/or require an assistive device for mobility.

Other clearances by Sichuan Ast Medical Equipment Co., Ltd.

  • K242722 — Manual Wheelchair (MASY23) (November 22, 2024)
  • K181795 — AST Model MA012 and MS019 Rehab Wheelchair (September 25, 2018)

Other clearances for product code IOR

  • K253632 — Manual Wheelchair (W50) (January 29, 2026)
  • K251886 — EmpowerRide NAVIGATOR (January 12, 2026)
  • K252828 — Manual Wheelchair (W47) (December 5, 2025)
  • K252825 — Manual Wheelchair (W45) (December 5, 2025)
  • K252687 — Manual Wheelchair (HM305-Air1, HM305-Air2) (November 21, 2025)
  • K250576 — Flexx Junior (FLX-J00, FLX-J50) (November 4, 2025)
  • K252517 — Manual Wheelchair (SYIV100A008) (October 3, 2025)
  • K241374 — Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) (February 28, 2025)
  • K243111 — Bowhead ERA Wheelchairs (January 10, 2025)
  • K242722 — Manual Wheelchair (MASY23) (November 22, 2024)