The following data is part of a premarket notification filed by Cymedica Orthopedics, Inc. with the FDA for Intellihab System.
|Device Name:||Intellihab System|
|Classification||Stimulator, Muscle, Powered|
|Applicant||CyMedica Orthopedics, Inc. 19120 N. Pima Rd. Scottsdale, AZ 85331|
CyMedica Orthopedics, Inc. 19120 N. Pima Rd. Scottsdale, AZ 85331
|CFR Regulation Number||890.5850 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|