The following data is part of a premarket notification filed by Ehti Medical Corp. with the FDA for Thee Thermastim.
| Device ID | K962703 |
| 510k Number | K962703 |
| Device Name: | THEE THERMASTIM |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | EHTI MEDICAL CORP. 2391 N.E. LOOP 410, STE #404 San Antonio, TX 78217 |
| Contact | James B Bingham |
| Correspondent | James B Bingham EHTI MEDICAL CORP. 2391 N.E. LOOP 410, STE #404 San Antonio, TX 78217 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-12 |
| Decision Date | 1997-02-21 |