K182163 is an FDA 510(k) clearance for the Shear Stress Therapeutics SST 3000. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Shear Stress Therapeutics, LLC (Tulsa, US). The FDA issued a Cleared decision on July 9, 2019, 333 days after receiving the submission on August 10, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K182163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2018 |
| Decision Date | July 09, 2019 |
| Days to Decision | 333 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |