Home / 510(k) Clearances / K031618

510(k) K031618

COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 by Comfort Orthopedic Co., Ltd. — Product Code IPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2003
Date Received
May 23, 2003
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 Comfort Orthopedic Co., Ltd.

  • K102734 — COMFORT STANDING WHEELCHAIR, HERO SERIES (December 14, 2010)
  • K072712 — COMFORT ELECTRIC SCOOTER, LY-EW408 (October 31, 2007)
  • K072711 — COMFORT POWERED WHEELCHAIR, LY-EB 206 (October 31, 2007)
  • K063030 — COMFORT SCOOTER MODEL LY-EW406 (December 4, 2006)
  • K063032 — COMFORT SCOOTER, MODEL LY-EW415 (October 16, 2006)
  • K031621 — HERO 1, MODEL LY-ESB220 (January 22, 2004)
  • K030356 — COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 (May 20, 2003)
  • K030355 — COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 (May 20, 2003)
  • K023581 — COMFORT AGILE SCOOTER, LY-EW303 (December 2, 2002)
  • K021910 — COMFORT DREAMRIDER SCOOTER, LY-EW402 (October 11, 2002)

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)
  • K191376 — Modular Power Standing System (August 13, 2019)
  • K172384 — Quickie(r) Q700-UP M (January 16, 2018)
  • K163451 — Action Trackstander models TR1816, TR1820, TR2016, and TR2020 (January 12, 2018)