The following data is part of a premarket notification filed by Medical Equipment Designs, Inc. with the FDA for Meditherm.
| Device ID | K894152 |
| 510k Number | K894152 |
| Device Name: | MEDITHERM |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | MEDICAL EQUIPMENT DESIGNS, INC. 601 EAST BROADWAY SUITE 203-A Jefferson City, TN 37760 |
| Contact | Barton Haggard |
| Correspondent | Barton Haggard MEDICAL EQUIPMENT DESIGNS, INC. 601 EAST BROADWAY SUITE 203-A Jefferson City, TN 37760 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-14 |
| Decision Date | 1990-06-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEDITHERM 75341071 not registered Dead/Abandoned |
TCP/RELIABLE INC. 1997-08-14 |