The following data is part of a premarket notification filed by Lsi Intl., Inc. with the FDA for S.p. 100.
| Device ID | K970696 |
| 510k Number | K970696 |
| Device Name: | S.P. 100 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | LSI INTL., INC. 8849 BOND Overland Park, KS 66214 |
| Contact | James C Lane |
| Correspondent | Gordon Gillerman UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1997-02-25 |
| Decision Date | 1997-03-18 |