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510(k) K102734

COMFORT STANDING WHEELCHAIR, HERO SERIES by Comfort Orthopedic Co., Ltd. — Product Code IPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2010
Date Received
September 22, 2010
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.

  • 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)
  • K031618 — COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 (December 18, 2003)
  • 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)
  • K022369 — COMFORT WINDJOY SCOOTER, MODEL LY-EW302 (October 11, 2002)

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