K191113 is an FDA 510(k) clearance for the geko T-2 and geko T-3 Neuromuscular Stimulators. 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 September 18, 2019, 145 days after receiving the submission on April 26, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K191113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2019 |
| Decision Date | September 18, 2019 |
| Days to Decision | 145 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 |