BODY WARMER (SHAKE-N-WARM)— 510(k) K760441

Name: FDA 510(k) clearance K760441
Creator: U.S. Food and Drug Administration
Published: 1976-09-16

Substantially Equivalent

Yamada Co., Ltd of Japan

FDA 510(k) clearance K760441 for BODY WARMER (SHAKE-N-WARM), Substantially Equivalent on 1976-09-16. Applicant: Yamada Co., Ltd of Japan. Device class: 1.

Clearance details

Applicant: Yamada Co., Ltd of Japan
Product code: Code IMD
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 1976-08-16
Decision date: 1976-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.