The following data is part of a premarket notification filed by Progressive Concepts, Inc. with the FDA for Biostim-hv.
| Device ID | K946298 |
| 510k Number | K946298 |
| Device Name: | BIOSTIM-HV |
| Classification | Stimulator, Muscle, Powered |
| Applicant | PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton, MD 21629 |
| Contact | W R Fischer |
| Correspondent | W R Fischer PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton, MD 21629 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-27 |
| Decision Date | 1995-05-11 |