The following data is part of a premarket notification filed by Biotone International, Inc. with the FDA for Passive Heat Pads.
| Device ID | K821692 |
| 510k Number | K821692 |
| Device Name: | PASSIVE HEAT PADS |
| Classification | Pad, Heating, Powered |
| Applicant | BIOTONE INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-08 |
| Decision Date | 1982-07-13 |