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510(k) K830425

TOILET SEAT RAISED by Maddak, Inc. — Product Code ILS

K830425 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "TOILET SEAT RAISED". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code ILS (Adaptor, Hygiene), a Class I device regulated under 21 CFR 890.5050. Maddak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
February 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Hygiene
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type

Other clearances by Maddak, Inc.

  • K841700 — WALK & ROLL (May 11, 1984)
  • K841698 — HEAT PACK (May 10, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K834311 — NIGHT TRAINER (March 30, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833177 — GLOSSECTOMY FEEDING SPOONS (October 31, 1983)

Other clearances for product code ILS

  • K852049 — MEDICAL TOILET SEAT (June 24, 1985)
  • K842651 — COMMODE CHAIR 98200 (August 7, 1984)
  • K831547 — RAISED TOILET SEATS & NAIL CLIPPERS (June 8, 1983)
  • K830853 — LAVATORY SEAT HEIGHTENER (June 8, 1983)
  • K830852 — SHOWER STOOL W/HANDLES (April 5, 1983)
  • K823641 — BATHING CHAIR FOR CHILD (January 21, 1983)
  • K823626 — DISPOSABLE TOOTH BRUSH (December 30, 1982)
  • K823606 — PLASTIC BREAK RESISTANT MIRROR (December 28, 1982)
  • K823155 — LAVATORY SEAT HEIGHTENER (November 5, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)

FDA data resources