RESI-WALKER— 510(k) K830848

Name: FDA 510(k) clearance K830848
Creator: U.S. Food and Drug Administration
Published: 1983-04-05

Substantially Equivalent

Lic-Orthion

FDA 510(k) clearance K830848 for RESI-WALKER, Substantially Equivalent on 1983-04-05. Applicant: Lic-Orthion. Device class: 1.

Clearance details

Applicant: Lic-Orthion
Product code: Code ITJ
Device class: Class 1
Regulation: 21 CFR 890.3825
Advisory panel: Physical Medicine
Date received: 1983-03-17
Decision date: 1983-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITJ

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K833869 — CHILD'S WALKER1983-11-29
K833195 — UMBRELLA WALKER1983-10-27
K830784 — WALK N ROLL1983-05-25
K823105 — RESI-WALKER1982-11-05
K821404 — LIGHT WEIGHT ALUMINUM WALKER1982-05-21

More clearances from Lic-Orthion

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K891649 — PATIENT EXAMINATION GLOVES (LATEX)1989-04-04
K862022 — LIC-ORTHION MULTI-THERAPY TREATMENT TABLE1986-06-19
K854729 — ADAM (ABSORBENT INCONTINENCE SHIELD)1986-02-06
K854730 — DAISY (ABSORBENT INCONTINENCE SHIELD)1986-02-06
K851470 — BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR1985-06-12

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.