THERMOELASTOMER HOT/COLD COMPRESS-7187-— 510(k) K823650

Name: FDA 510(k) clearance K823650
Creator: U.S. Food and Drug Administration
Published: 1983-01-21

Substantially Equivalent

Fred Sammons, Inc.

FDA 510(k) clearance K823650 for THERMOELASTOMER HOT/COLD COMPRESS-7187-, Substantially Equivalent on 1983-01-21. Applicant: Fred Sammons, Inc.. Device class: 1.

Clearance details

Applicant: Fred Sammons, Inc.
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1982-12-06
Decision date: 1983-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K831549 — ARM SLINGS1983-06-30
K831548 — SPLINTS1983-06-27
K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE1983-06-24

Adverse events under product code IME

product code IME

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.