CHILD'S WALKER— 510(k) K833869

Name: FDA 510(k) clearance K833869
Creator: U.S. Food and Drug Administration
Published: 1983-11-29

Substantially Equivalent

Kaye Products, Inc.

FDA 510(k) clearance K833869 for CHILD'S WALKER, Substantially Equivalent on 1983-11-29. Applicant: Kaye Products, Inc.. Device class: 1.

Clearance details

Applicant: Kaye Products, Inc.
Product code: Code ITJ
Device class: Class 1
Regulation: 21 CFR 890.3825
Advisory panel: Physical Medicine
Date received: 1983-11-08
Decision date: 1983-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K833195 — UMBRELLA WALKER1983-10-27
K830784 — WALK N ROLL1983-05-25
K830848 — RESI-WALKER1983-04-05
K823105 — RESI-WALKER1982-11-05
K821404 — LIGHT WEIGHT ALUMINUM WALKER1982-05-21

More clearances from Kaye Products, Inc.

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K924848 — KAYE SCOOT-ABOUT, MODEL SB11993-02-12
K923095 — KAYE MODEL KIAO PELVIC/THIGH STABILIZER1992-07-21
K922061 — CHAIR, ADJUSTABLE, MECHANICAL1992-05-26
K885330 — WHEELCHAIR, MECHANICAL1989-02-03
K830466 — BARS, PARALLEL, EXERCISE1983-03-09

Adverse events under product code ITJ

product code ITJ

Death: 8
Injury: 571
Other: 2
Total: 581

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.