HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P— 510(k) K102236
Substantially EquivalentD.T. Davis Enterprises Ltd. T/A Hovertech Int'L
FDA 510(k) clearance K102236 for HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P, Substantially Equivalent on 2010-11-18. Applicant: D.T. Davis Enterprises Ltd. T/A Hovertech Int'L.
Clearance details
- Applicant
- D.T. Davis Enterprises Ltd. T/A Hovertech Int'L
- Product code
- Code INK
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
Adverse events under product code INK
product code INK- Malfunction
- 708
- Other
- 1
- Total
- 709
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.