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510(k) K863450

SULKY SPECIAL by Asc Corp. — Product Code LBE

K863450 is an FDA 510(k) premarket notification submitted by Asc Corp. for the device "SULKY SPECIAL". The FDA issued a decision of Substantially Equivalent on October 23, 1986. The device falls under product code LBE (Stroller, Adaptive), a Class I device regulated under 21 CFR 890.3850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1986
Date Received
September 3, 1986
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 for product code LBE

  • K223533 — Little Wave Arc; Little Wave Flip (August 31, 2023)
  • K130644 — PEDIATRIC FOLDING WHEELCHAIR (October 16, 2013)
  • 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)

FDA data resources