The following data is part of a premarket notification filed by Ecp Health Inc. with the FDA for Ecp Health System, Model 2005.
| Device ID | K052611 |
| 510k Number | K052611 |
| Device Name: | ECP HEALTH SYSTEM, MODEL 2005 |
| Classification | Device, Counter-pulsating, External |
| Applicant | ECP HEALTH INC. 8416 PRAIRIE ROSE LANE Fort Worth, TX 76123 |
| Contact | Shamon Huang |
| Correspondent | Shamon Huang ECP HEALTH INC. 8416 PRAIRIE ROSE LANE Fort Worth, TX 76123 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-22 |
| Decision Date | 2006-04-26 |
| Summary: | summary |