The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Sx90 (tm),model 4800s.
| Device ID | K912348 |
| 510k Number | K912348 |
| Device Name: | SX90 (TM),MODEL 4800S |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Contact | Bruce A.macfarlane |
| Correspondent | Bruce A.macfarlane MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-28 |
| Decision Date | 1991-06-24 |