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510(k) K810676

CONVAID CRUISER CP4M by Convaid Products, Inc. — Product Code LBE

K810676 is an FDA 510(k) premarket notification submitted by Convaid Products, Inc. for the device "CONVAID CRUISER CP4M". The FDA issued a decision of Substantially Equivalent on March 26, 1981. The device falls under product code LBE (Stroller, Adaptive), a Class I device regulated under 21 CFR 890.3850. Convaid Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1981
Date Received
March 12, 1981
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 Convaid Products, Inc.

  • K171017 — Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13 (October 18, 2017)
  • K140416 — TREKKER, TREKKER TRANSIT (September 17, 2014)
  • K120501 — CHAMP CHAMP TRANSIT (September 20, 2012)
  • K032402 — RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T, (September 24, 2003)
  • K840250 — CARRIER (February 9, 1984)
  • K833195 — UMBRELLA WALKER (October 27, 1983)
  • K822992 — PEOPLE MOVER (October 27, 1982)
  • K781947 — STROLLER, THERAPY (December 4, 1978)

Other clearances for product code LBE

  • K223533 — Little Wave Arc; Little Wave Flip (August 31, 2023)
  • 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)
  • K781947 — STROLLER, THERAPY (December 4, 1978)

FDA data resources