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510(k) K981837

TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS by Motion Concepts — Product Code ITI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1998
Date Received
May 26, 1998
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 by Motion Concepts

  • K191376 — Modular Power Standing System (August 13, 2019)
  • K182995 — Bariatric Power Positioning System (BPPS) (March 8, 2019)
  • K150574 — Modular Power Positioning System (June 30, 2015)
  • K023426 — TRX VERTICAL POSITIONER (November 21, 2002)
  • K021264 — TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECL (July 30, 2002)
  • K994241 — TRX-CG POWER TILT AND RECLINE SYSTEM (January 13, 2000)
  • K990544 — TRX-CG POWER TILT AND RECLINE SYSTEM (April 8, 1999)
  • K970521 — TRX POWER TILT AND RECLINE SYSTEM (March 31, 1997)

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)