STRYKER 5050 STRECHAIR— 510(k) K941738

Name: FDA 510(k) clearance K941738
Creator: U.S. Food and Drug Administration
Published: 1994-05-06

Substantially Equivalent

Stryker Medical

FDA 510(k) clearance K941738 for STRYKER 5050 STRECHAIR, Substantially Equivalent on 1994-05-06. Applicant: Stryker Medical. Device class: 1.

Clearance details

Applicant: Stryker Medical
Product code: Code INM
Device class: Class 1
Regulation: 21 CFR 890.3100
Advisory panel: Physical Medicine
Date received: 1994-04-07
Decision date: 1994-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code INM

product code INM

Death: 3
Total: 3

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.