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510(k) K252517

Manual Wheelchair (SYIV100A008) by Ningbo Shenyu Medical Equipment Co.,Ltd — Product Code IOR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2025
Date Received
August 11, 2025
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 Ningbo Shenyu Medical Equipment Co.,Ltd

  • K253599 — Electric Wheelchair (W-A807, W-A807L) (February 17, 2026)
  • K231110 — Manual Wheelchair (A006) (June 16, 2023)
  • K201461 — Manual Wheelchair, Model A011 (May 21, 2021)

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)
  • 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)
  • K242560 — Manual Wheelchair (SYIV100-CA9221) (October 24, 2024)