The following data is part of a premarket notification filed by Neurocom International, Inc. with the FDA for Balance Manager.
| Device ID | K946229 |
| 510k Number | K946229 |
| Device Name: | BALANCE MANAGER |
| Classification | Platform, Force-measuring |
| Applicant | NEUROCOM INTERNATIONAL, INC. 9570 S.E. LAWNFIELD RD. Clackamas, OR 97015 |
| Contact | Jack Fassel |
| Correspondent | Jack Fassel NEUROCOM INTERNATIONAL, INC. 9570 S.E. LAWNFIELD RD. Clackamas, OR 97015 |
| Product Code | KHX |
| CFR Regulation Number | 890.1575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-22 |
| Decision Date | 1995-08-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BALANCE MANAGER 78795273 3299729 Live/Registered |
NATUS MEDICAL INCORPORATED 2006-01-20 |
![]() BALANCE MANAGER 75087487 2181077 Dead/Cancelled |
UtiliCorp Holdings Inc. 1996-04-12 |