MANOY WALKING AID— 510(k) K770166

Name: FDA 510(k) clearance K770166
Creator: U.S. Food and Drug Administration
Published: 1977-01-28

Substantially Equivalent

Maddak, Inc.

FDA 510(k) clearance K770166 for MANOY WALKING AID, Substantially Equivalent on 1977-01-28. Applicant: Maddak, Inc.. Device class: 1.

Clearance details

Applicant: Maddak, Inc.
Product code: Code ITJ
Device class: Class 1
Regulation: 21 CFR 890.3825
Advisory panel: Physical Medicine
Date received: 1977-01-25
Decision date: 1977-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Maddak, Inc.

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K841700 — WALK & ROLL1984-05-11
K841695 — CRAWLER1984-05-10
K841698 — HEAT PACK1984-05-10
K841691 — SPLIT SEAT POSITIONING CHAIR1984-05-09
K841692 — PRONE STANDER1984-05-09

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.