K163125 is an FDA 510(k) clearance for the geko™ T-2 and geko™ Plus R-2 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 April 10, 2017, 153 days after receiving the submission on November 8, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K163125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2016 |
| Decision Date | April 10, 2017 |
| Days to Decision | 153 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 |