The following data is part of a premarket notification filed by Cymedica Orthopedics, Inc. with the FDA for Intellihab System.
| Device ID | K210604 |
| 510k Number | K210604 |
| Device Name: | Intellihab System |
| Classification | Stimulator, Muscle, Powered |
| Applicant | CyMedica Orthopedics, Inc. 19120 N. Pima Rd. Scottsdale, AZ 85331 |
| Contact | Kereshmeh Shahriari |
| Correspondent | Kereshmeh Shahriari CyMedica Orthopedics, Inc. 19120 N. Pima Rd. Scottsdale, AZ 85331 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2021-06-03 |