The following data is part of a premarket notification filed by Lsi Intl., Inc. with the FDA for Ms400.
| Device ID | K984113 |
| 510k Number | K984113 |
| Device Name: | MS400 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | LSI INTL., INC. 8849 BOND Overland Park, KS 66214 |
| Contact | James C Lane |
| Correspondent | James C Lane LSI INTL., INC. 8849 BOND Overland Park, KS 66214 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-17 |
| Decision Date | 1999-01-28 |