OMBRON TWIN-HEAD MASSAGER MODEL HM-101— 510(k) K935462
Substantially EquivalentOmron Healthcare, Inc.
FDA 510(k) clearance K935462 for OMBRON TWIN-HEAD MASSAGER MODEL HM-101, Substantially Equivalent on 1994-03-04. Applicant: Omron Healthcare, Inc.. Device class: 1.
Clearance details
- Applicant
- Omron Healthcare, Inc.
- Product code
- Code ISA
- Device class
- Class 1
- Regulation
- 21 CFR 890.5660
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
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Adverse events under product code ISA
product code ISA- Death
- 3
- Other
- 1
- Total
- 4
Source: openFDA MAUDE database, through . 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.