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510(k) K833869

CHILD'S WALKER by Kaye Products, Inc. — Product Code ITJ

K833869 is an FDA 510(k) premarket notification submitted by Kaye Products, Inc. for the device "CHILD'S WALKER". The FDA issued a decision of Substantially Equivalent on November 29, 1983. The device falls under product code ITJ (Walker, Mechanical), a Class I device regulated under 21 CFR 890.3825. Kaye Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1983
Date Received
November 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Walker, Mechanical
Device Class
Class I
Regulation Number
890.3825
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)
  • K830466 — BARS, PARALLEL, EXERCISE (March 9, 1983)
  • K830560 — EXERCISER, PASSIVE, NON MEASURING (March 9, 1983)
  • K820591 — MECHANICAL CHAIR (March 15, 1982)
  • K812399 — CHAIR, ADJUSTABLE, MECHANICAL (September 14, 1981)
  • K812319 — THERAPY BENCH (August 31, 1981)
  • K810609 — PEDIATRIC POSITION HOLDER (March 20, 1981)

Other clearances for product code ITJ

  • K833195 — UMBRELLA WALKER (October 27, 1983)
  • K830784 — WALK N ROLL (May 25, 1983)
  • K830848 — RESI-WALKER (April 5, 1983)
  • K823105 — RESI-WALKER (November 5, 1982)
  • K821404 — LIGHT WEIGHT ALUMINUM WALKER (May 21, 1982)
  • K820711 — WALK-A-CYCLE (April 8, 1982)
  • K811485 — WALKER/CRUTCH BAG (June 16, 1981)
  • K792064 — DELTA ROLLING SELF-LICKING WALKER (October 30, 1979)
  • K790529 — WALKING AID (April 3, 1979)
  • K772049 — WALKING AID (November 11, 1977)

FDA data resources