DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES— 510(k) K091672
Substantially EquivalentShuyou Electric Medical Science Co., Ltd.
FDA 510(k) clearance K091672 for DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES, Substantially Equivalent on 2009-12-04. Applicant: Shuyou Electric Medical Science Co., Ltd..
Clearance details
- Applicant
- Shuyou Electric Medical Science Co., Ltd.
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.