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510(k) K223533

Little Wave Arc; Little Wave Flip by Ki Mobility, LLC — Product Code LBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2023
Date Received
November 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stroller, Adaptive
Device Class
Class I
Regulation Number
890.3850
Review Panel
PM
Submission Type

Other clearances by Ki Mobility, LLC

  • K201869 — Ki Power Tilt System (September 5, 2023)
  • K200583 — Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL (September 5, 2023)
  • K223527 — Little Wave Clik, Rogue XP, Little Wave XP, Spark (August 31, 2023)
  • K062660 — CATALYSY (October 24, 2006)

Other clearances for product code LBE

  • K130644 — PEDIATRIC FOLDING WHEELCHAIR (October 16, 2013)
  • K863450 — SULKY SPECIAL (October 23, 1986)
  • K862888 — PERAMBULATOR (STROLLER) (August 13, 1986)
  • K840250 — CARRIER (February 9, 1984)
  • K820591 — MECHANICAL CHAIR (March 15, 1982)
  • K810676 — CONVAID CRUISER CP4M (March 26, 1981)
  • K781947 — STROLLER, THERAPY (December 4, 1978)