510(k) K935462— OMBRON TWIN-HEAD MASSAGER MODEL HM-101

Substantially Equivalent

Omron Healthcare, Inc.

Clearance details

Applicant: Omron Healthcare, Inc.
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1993-11-12
Decision date: 1994-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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.