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510(k) K140023

ELEVATION by Pdg Product Design Group, Inc. — Product Code IOR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2014
Date Received
January 6, 2014
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 Pdg Product Design Group, Inc.

  • K163432 — Stellar LEAP (June 27, 2017)
  • K063736 — FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 (January 17, 2007)
  • K061475 — ASTROTILT MANUAL WHEELCHAIR (June 14, 2006)
  • K990557 — THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR (March 22, 1999)
  • K971389 — ECLIPSE 400 MANUALLY OPERATED WHEELCAIR (May 9, 1997)
  • K970311 — BENTLEY MANUALLY OPERATED WHEELCHAIR (February 14, 1997)
  • K961743 — ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR (May 29, 1996)

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)