K953442
Substantially Equivalent for Some IndicationsRESTORE, THERMACELLS (HOT PACK I)
- Applicant
- Neal Dunning Assoc., Inc.
- Product code
- IMD
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Bethesda, MD, US
Adverse events under product code IMD
product code IMD- Death
- 3
- Injury
- 600
- Total
- 603
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.