The following data is part of a premarket notification filed by Intl. Diathermics Research, Inc. with the FDA for Solex Therapeutic Pad.
| Device ID | K861383 |
| 510k Number | K861383 |
| Device Name: | SOLEX THERAPEUTIC PAD |
| Classification | Pad, Heating, Powered |
| Applicant | INTL. DIATHERMICS RESEARCH, INC. 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy INTL. DIATHERMICS RESEARCH, INC. 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-14 |
| Decision Date | 1986-04-18 |