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510(k) K791423

TOILET TRAINER FOR HANDICAPPED CHILD by Kaye Products, Inc. — Product Code ILS

K791423 is an FDA 510(k) premarket notification submitted by Kaye Products, Inc. for the device "TOILET TRAINER FOR HANDICAPPED CHILD". The FDA issued a decision of Substantially Equivalent on August 10, 1979. The device falls under product code ILS (Adaptor, Hygiene), a Class I device regulated under 21 CFR 890.5050. Kaye Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1979
Date Received
July 31, 1979
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 Kaye Products, Inc.

  • K924848 — KAYE SCOOT-ABOUT, MODEL SB1 (February 12, 1993)
  • K923095 — KAYE MODEL KIAO PELVIC/THIGH STABILIZER (July 21, 1992)
  • K922061 — CHAIR, ADJUSTABLE, MECHANICAL (May 26, 1992)
  • K885330 — WHEELCHAIR, MECHANICAL (February 3, 1989)
  • K833869 — CHILD'S WALKER (November 29, 1983)
  • K830560 — EXERCISER, PASSIVE, NON MEASURING (March 9, 1983)
  • K830466 — BARS, PARALLEL, EXERCISE (March 9, 1983)
  • K820591 — MECHANICAL CHAIR (March 15, 1982)
  • K812399 — CHAIR, ADJUSTABLE, MECHANICAL (September 14, 1981)
  • K812319 — THERAPY BENCH (August 31, 1981)

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)
  • K830425 — TOILET SEAT RAISED (May 9, 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)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)

FDA data resources