The following data is part of a premarket notification filed by Burke Neutech, Inc. with the FDA for Thermaflex, Model Sd 55 C.p.m.h..
| Device ID | K945803 |
| 510k Number | K945803 |
| Device Name: | THERMAFLEX, MODEL SD 55 C.P.M.H. |
| Classification | Exerciser, Finger, Powered |
| 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 | JFA |
| CFR Regulation Number | 890.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-28 |
| Decision Date | 1995-05-11 |