The following data is part of a premarket notification filed by Cymedica Orthopedics, Inc. with the FDA for Cymedica E-vive™ System; Cy-1000.
| Device ID | K163067 |
| 510k Number | K163067 |
| Device Name: | CyMedica E-vive™ System; CY-1000 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | CyMedica Orthopedics, Inc. 19120 N. Pima Rd. Suite 135 Scottsdale, AZ 85255 |
| Contact | Kereshmeh Shahriari |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | KQX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-11-02 |
| Decision Date | 2016-12-01 |
| Summary: | summary |