The following data is part of a premarket notification filed by Deltatherm with the FDA for Delta Therm Cold Therapy System.
| Device ID | K945399 |
| 510k Number | K945399 |
| Device Name: | DELTA THERM COLD THERAPY SYSTEM |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | DELTATHERM 7038 RIVER RD. Pittsburgh, PA 15225 |
| Contact | Kirk A Dobbs |
| Correspondent | Kirk A Dobbs DELTATHERM 7038 RIVER RD. Pittsburgh, PA 15225 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-04 |
| Decision Date | 1995-03-07 |