K193045 is an FDA 510(k) clearance for the geko™ W-2. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Firstkind Limited (High Wycombe, GB). The FDA issued a Cleared decision on January 18, 2020, 78 days after receiving the submission on November 1, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K193045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2019 |
| Decision Date | January 18, 2020 |
| Days to Decision | 78 days |
| Submission Type | Special |
| 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 |