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510(k) K821903

DISC-O-AID by M. Dahm International Aps — Product Code IKX

K821903 is an FDA 510(k) premarket notification submitted by M. Dahm International Aps for the device "DISC-O-AID". The FDA issued a decision of Substantially Equivalent on July 20, 1982. The device falls under product code IKX (Aid, Transfer), a Class I device regulated under 21 CFR 890.5050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1982
Date Received
June 28, 1982
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 for product code IKX

  • K862895 — TRICYCLES (August 13, 1986)
  • 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)
  • K821010 — BATHTUB TRANSFER BENCH (April 21, 1982)
  • K813629 — BK-6111 HI-D TRANSFER BOARD (January 19, 1982)

FDA data resources