The following data is part of a premarket notification filed by Omron Electronics, Inc. with the FDA for Omron Pulse Stimulator Model Hv-f05.
| Device ID | K902255 |
| 510k Number | K902255 |
| Device Name: | OMRON PULSE STIMULATOR MODEL HV-F05 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | OMRON ELECTRONICS, INC. 1615 L STREET, N.W. SUITE 1200 Washington, DC 20036 |
| Contact | Terry G Mahn |
| Correspondent | Terry G Mahn OMRON ELECTRONICS, INC. 1615 L STREET, N.W. SUITE 1200 Washington, DC 20036 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-21 |
| Decision Date | 1990-10-31 |