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510(k) K862895

TRICYCLES by Mednet, Inc. — Product Code IKX

K862895 is an FDA 510(k) premarket notification submitted by Mednet, Inc. for the device "TRICYCLES". The FDA issued a decision of Substantially Equivalent on August 13, 1986. The device falls under product code IKX (Aid, Transfer), a Class I device regulated under 21 CFR 890.5050. Mednet, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1986
Date Received
July 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aid, Transfer
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type

Other clearances by Mednet, Inc.

  • K955782 — MED-NET STOPCOCKS (February 21, 1996)
  • K862883 — ORTHOPEDIC SEATS (August 14, 1986)
  • K862887 — UPHOLSTERED BUCKET SEAT (August 14, 1986)
  • K862892 — CASTER CAR (August 14, 1986)
  • K862885 — CAR SEAT (August 14, 1986)
  • K862889 — KIRO, WHEELCHAIR FOR CHILDREN (August 13, 1986)
  • K862893 — VENTRAL STANDING UNIT (August 13, 1986)
  • K862886 — KOOYCHAIR (PEDIATRIC) (August 13, 1986)
  • K862894 — SCHOOLTABLE (August 13, 1986)
  • K862890 — TOILET/SHOWER CHAIR (August 13, 1986)

Other clearances for product code IKX

  • K842650 — WALL GRAB BARS 98130-98136 (August 10, 1984)
  • K831541 — TUB TRANSFER BENCH BK6481 (June 2, 1983)
  • K823639 — BOARD TO TRANSFER PARALYZED PATIENT FROM (January 21, 1983)
  • K823640 — BATH TUB SAFETY BAR (January 21, 1983)
  • K823634 — CHAIR OR BED LEG EXTENDERS (December 28, 1982)
  • K823154 — SHOWER STOOL W/HANDLES (November 5, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (November 5, 1982)
  • K821903 — DISC-O-AID (July 20, 1982)
  • K821010 — BATHTUB TRANSFER BENCH (April 21, 1982)
  • K813629 — BK-6111 HI-D TRANSFER BOARD (January 19, 1982)

FDA data resources