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510(k) K781947

STROLLER, THERAPY by Convaid Products, Inc. — Product Code LBE

K781947 is an FDA 510(k) premarket notification submitted by Convaid Products, Inc. for the device "STROLLER, THERAPY". The FDA issued a decision of Substantially Equivalent on December 4, 1978. 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
December 4, 1978
Date Received
November 21, 1978
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)
  • K810676 — CONVAID CRUISER CP4M (March 26, 1981)

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)
  • K810676 — CONVAID CRUISER CP4M (March 26, 1981)

FDA data resources