The following data is part of a premarket notification filed by Pci with the FDA for Pci 4000.
| Device ID | K932610 |
| 510k Number | K932610 |
| Device Name: | PCI 4000 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | PCI 23041 STEARN CIRCLE Lake Forest, CA 92630 |
| Contact | Howard M Holstien |
| Correspondent | Howard M Holstien PCI 23041 STEARN CIRCLE Lake Forest, CA 92630 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-28 |
| Decision Date | 1993-08-19 |