PROVEST-PROTECTIVE RESTRAINT— 510(k) K971561

Name: FDA 510(k) clearance K971561
Creator: U.S. Food and Drug Administration
Published: 1997-07-14

Substantially Equivalent

Jemm Medical Products

FDA 510(k) clearance K971561 for PROVEST-PROTECTIVE RESTRAINT, Substantially Equivalent on 1997-07-14. Applicant: Jemm Medical Products. Device class: 1.

Clearance details

Applicant: Jemm Medical Products
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 1997-04-29
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancaster, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.