The following data is part of a premarket notification filed by Burke Neutech, Inc. with the FDA for Ts1000 Portable Disposable Cold Therapy System.
| Device ID | K940160 |
| 510k Number | K940160 |
| Device Name: | TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | BURKE NEUTECH, INC. 11701 S. BELCHER RD. SUITE 119 Largo, FL 34643 -5117 |
| Contact | Robert E Burke |
| Correspondent | Robert E Burke BURKE NEUTECH, INC. 11701 S. BELCHER RD. SUITE 119 Largo, FL 34643 -5117 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-12 |
| Decision Date | 1994-05-27 |