TRACTION ACCESSORIES— 510(k) K830244

Name: FDA 510(k) clearance K830244
Creator: U.S. Food and Drug Administration
Published: 1983-03-09

Substantially Equivalent

Warm & Form, Orthopedic Materials

FDA 510(k) clearance K830244 for TRACTION ACCESSORIES, Substantially Equivalent on 1983-03-09. Applicant: Warm & Form, Orthopedic Materials. Device class: 1.

Clearance details

Applicant: Warm & Form, Orthopedic Materials
Product code: Code HST
Device class: Class 1
Regulation: 21 CFR 888.5850
Advisory panel: Orthopedic
Date received: 1983-01-25
Decision date: 1983-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Warm & Form, Orthopedic Materials

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K830245 — HEAD HALTER1983-03-09
K830243 — ABDUCTION PILLOW1983-03-08
K830246 — CAST SHOE, CAST BOOT1983-02-18
K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL)1982-12-30
K823659 — PELVIC TRACTION BELT1982-12-30

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.