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510(k) K021264

TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT by Motion Concepts — Product Code ITI

K021264 is an FDA 510(k) premarket notification submitted by Motion Concepts for the device "TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT". The FDA issued a decision of Substantially Equivalent on July 30, 2002. The device falls under product code ITI (Wheelchair, Powered), a Class II device regulated under 21 CFR 890.3860. Motion Concepts has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2002
Date Received
April 22, 2002
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)
  • K994241 — TRX-CG POWER TILT AND RECLINE SYSTEM (January 13, 2000)
  • K990544 — TRX-CG POWER TILT AND RECLINE SYSTEM (April 8, 1999)
  • K981837 — TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS (July 9, 1998)
  • K970521 — TRX POWER TILT AND RECLINE SYSTEM (March 31, 1997)

Other clearances for product code ITI

  • K261149 — Electric Wheelchair (DY611A-2, DY612A-1) (July 10, 2026)
  • K261396 — Electric Wheelchair (July 8, 2026)
  • K261164 — Electric wheelchair (XW-LY007 ) (July 7, 2026)
  • K260937 — Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) (June 24, 2026)
  • K253812 — Power Wheelchair (W5915B, W5915C, W5915D) (June 18, 2026)
  • K260335 — Electric Wheelchair (S500-6) (June 15, 2026)
  • K261175 — WHILL (WHILL Model C2) (June 12, 2026)
  • K260056 — Power Wheelchair (N5515A, N5516, N5517A, N5519) (June 5, 2026)
  • K260373 — Electric Wheelchair (DF506) (June 3, 2026)
  • K253241 — Electric Wheelchair (Y207BL) (May 13, 2026)

FDA data resources