3M HEAT COMFORT PORTABLE SELF-HEATING PAD— 510(k) K901778
Substantially Equivalent3M Company
FDA 510(k) clearance K901778 for 3M HEAT COMFORT PORTABLE SELF-HEATING PAD, Substantially Equivalent on 1990-05-01. Applicant: 3M Company. Device class: 1.
Clearance details
- Applicant
- 3M Company
- Product code
- Code IMD
- Device class
- Class 1
- Regulation
- 21 CFR 890.5710
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cottae Grove, MN, US
Recent devices under product code IMD
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- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
- K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
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.