The following data is part of a premarket notification filed by Urologics, Inc. with the FDA for }iustim - Electronic Neuromuscular Stimulator.
| Device ID | K850167 |
| 510k Number | K850167 |
| Device Name: | }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | UROLOGICS, INC. 1538 CATRON AVE., S.E. Albuquerque, NM 87123 |
| Contact | Edwin H Barsis |
| Correspondent | Edwin H Barsis UROLOGICS, INC. 1538 CATRON AVE., S.E. Albuquerque, NM 87123 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-16 |
| Decision Date | 1985-04-09 |