PELVIC WHEELCHAIR RESTRAINT— 510(k) K771715

Name: FDA 510(k) clearance K771715
Creator: U.S. Food and Drug Administration
Published: 1977-09-28

Substantially Equivalent

Medical Restraints, Inc.

FDA 510(k) clearance K771715 for PELVIC WHEELCHAIR RESTRAINT, Substantially Equivalent on 1977-09-28. Applicant: Medical Restraints, Inc.. Device class: 1.

Clearance details

Applicant: Medical Restraints, Inc.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 1977-09-12
Decision date: 1977-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Medical Restraints, Inc.

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K771629 — HAND RESTRAINT1977-09-30
K771630 — LIMB RESTRAINT1977-09-30
K771636 — BODY RESTRAINT1977-09-30
K771632 — FINGER MITT RESTRAINT1977-09-28
K771634 — VEST RESTRAINT1977-09-28

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.