The following data is part of a premarket notification filed by Nicolet Biomedical, Inc. with the FDA for Biorehab System.
| Device ID | K011823 |
| 510k Number | K011823 |
| Device Name: | BIOREHAB SYSTEM |
| Classification | Device, Biofeedback |
| Applicant | NICOLET BIOMEDICAL, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Contact | Gary J Syring |
| Correspondent | Gary J Syring NICOLET BIOMEDICAL, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-11 |
| Decision Date | 2001-09-06 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOREHAB SYSTEM 75875470 2525896 Dead/Cancelled |
Enhanced Mobility Technologies, Inc. 2000-01-03 |