THE ROBOLITE— 510(k) K964460

Name: FDA 510(k) clearance K964460
Creator: U.S. Food and Drug Administration
Published: 1997-01-24

Substantially Equivalent

Shai Syg Motion and Innovations, Ltd.

FDA 510(k) clearance K964460 for THE ROBOLITE, Substantially Equivalent on 1997-01-24. Applicant: Shai Syg Motion and Innovations, Ltd.. Device class: 1.

Clearance details

Applicant: Shai Syg Motion and Innovations, Ltd.
Product code: Code JQP
Device class: Class 1
Regulation: 21 CFR 862.2100
Advisory panel: Clinical Chemistry
Date received: 1996-11-07
Decision date: 1997-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Efrat, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

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.