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 |