K210604 is an FDA 510(k) clearance for the Intellihab System. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Cymedica Orthopedics, Inc. (Scottsdale, US). The FDA issued a Cleared decision on June 3, 2021, 94 days after receiving the submission on March 1, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K210604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2021 |
| Decision Date | June 03, 2021 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |