The following data is part of a premarket notification filed by Scottcare Corporation with the FDA for Genesis Ecp.
| Device ID | K081359 |
| 510k Number | K081359 |
| Device Name: | GENESIS ECP |
| Classification | Device, Counter-pulsating, External |
| Applicant | SCOTTCARE CORPORATION 4791 WEST 150TH ST. Cleveland, OH 44135 |
| Contact | Ronald J Clines |
| Correspondent | Ronald J Clines SCOTTCARE CORPORATION 4791 WEST 150TH ST. Cleveland, OH 44135 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-15 |
| Decision Date | 2008-05-29 |
| Summary: | summary |