SUSPENDER ORTHOPEDIC SUSPENSION DEVICE— 510(k) K860037

Name: FDA 510(k) clearance K860037
Creator: U.S. Food and Drug Administration
Published: 1986-01-21

Substantially Equivalent

Comfortex, Inc.

FDA 510(k) clearance K860037 for SUSPENDER ORTHOPEDIC SUSPENSION DEVICE, Substantially Equivalent on 1986-01-21. Applicant: Comfortex, Inc.. Device class: 1.

Clearance details

Applicant: Comfortex, Inc.
Product code: Code HST
Device class: Class 1
Regulation: 21 CFR 888.5850
Advisory panel: Orthopedic
Date received: 1986-01-06
Decision date: 1986-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winona, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HST

product code HST

Other: 1
Total: 1

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.