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510(k) K191376

Modular Power Standing System by Motion Concepts — Product Code IPL

K191376 is an FDA 510(k) premarket notification submitted by Motion Concepts for the device "Modular Power Standing System". The FDA issued a decision of Substantially Equivalent on August 13, 2019. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Motion Concepts has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2019
Date Received
May 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Standup
Device Class
Class II
Regulation Number
890.3900
Review Panel
PM
Submission Type

Other clearances by Motion Concepts

  • 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)
  • 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 IPL

  • K243783 — Walking rehabilitation training electric wheelchair (ZW518) (March 12, 2025)
  • K202728 — Action Trackchair Hawk (February 10, 2022)
  • K203761 — ParaMotion (January 21, 2022)
  • K191334 — Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04 (May 29, 2020)
  • K190682 — Explorer Mini (February 27, 2020)
  • K191874 — F5 Corpus VS (October 25, 2019)
  • K182257 — UPnRIDE (September 12, 2019)
  • K172384 — Quickie(r) Q700-UP M (January 16, 2018)
  • K163451 — Action Trackstander models TR1816, TR1820, TR2016, and TR2020 (January 12, 2018)
  • K150548 — Tek RMD (Tek Robotic Mobilization Device) (June 11, 2015)

FDA data resources