OMRON TRAVEL MASSAGER, MODEL HM-01— 510(k) K893029

Name: FDA 510(k) clearance K893029
Creator: U.S. Food and Drug Administration
Published: 1989-05-31

Substantially Equivalent

Omron Electronics, Inc.

FDA 510(k) clearance K893029 for OMRON TRAVEL MASSAGER, MODEL HM-01, Substantially Equivalent on 1989-05-31. Applicant: Omron Electronics, Inc.. Device class: 1.

Clearance details

Applicant: Omron Electronics, Inc.
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 1989-04-24
Decision date: 1989-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
Total: 4

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.