PASSIVE HEAT PADS— 510(k) K821692
Substantially EquivalentBiotone International, Inc.
FDA 510(k) clearance K821692 for PASSIVE HEAT PADS, Substantially Equivalent on 1982-07-13. Applicant: Biotone International, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotone International, Inc.
- Product code
- Code IRT
- Device class
- Class 2
- Regulation
- 21 CFR 890.5740
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code IRT
view allMore clearances from Biotone International, Inc.
view allAdverse events under product code IRT
product code IRT- Injury
- 668
- Total
- 668
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.