| K-number | K821692 |
| Device name | PASSIVE HEAT PADS |
| Applicant | Biotone International, Inc. |
| Product code | IRT |
| Device class | Class II |
| Decision date | Jul 13, 1982 |
| Decision | Substantially Equivalent |
| Regulation | 890.5740 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov