The following data is part of a premarket notification filed by Control Solutions, Inc. with the FDA for Control Solutions, Inc., Model Cs3102 Hvg.
| Device ID | K041146 |
| 510k Number | K041146 |
| Device Name: | CONTROL SOLUTIONS, INC., MODEL CS3102 HVG |
| Classification | Stimulator, Muscle, Powered |
| Applicant | CONTROL SOLUTIONS, INC. 508 WEST 5TH. AVE. Naperville, IL 60563 |
| Contact | Brett Walach |
| Correspondent | Jeremi Peck UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-06-08 |