The following data is part of a premarket notification filed by Maddak, Inc. with the FDA for Hydro-thero Pad.
| Device ID | K841697 |
| 510k Number | K841697 |
| Device Name: | HYDRO-THERO PAD |
| Classification | Pad, Heating, Powered |
| Applicant | MADDAK, 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 | 1984-04-23 |
| Decision Date | 1984-05-09 |