The following data is part of a premarket notification filed by Thermia, Inc. with the FDA for Dyna T-2000 Physical Therapy System.
| Device ID | K955808 |
| 510k Number | K955808 |
| Device Name: | DYNA T-2000 PHYSICAL THERAPY SYSTEM |
| Classification | Cabinet, Moist Steam |
| Applicant | THERMIA, INC. 4200 WEST 76TH ST. Edina, MN 55435 |
| Contact | Steven J Daffer |
| Correspondent | Steven J Daffer THERMIA, INC. 4200 WEST 76TH ST. Edina, MN 55435 |
| Product Code | IMB |
| CFR Regulation Number | 890.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1997-11-03 |