K890401
Substantially EquivalentGOLDEN MEAN MACHINE(TM) (CLASS 2)
- Applicant
- Bennett Ergonomic Labs, Inc.
- Product code
- ISD
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Largo, FL, US
Adverse events under product code ISD
product code ISD- Other
- 2
- Total
- 2
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.