K160299 is an FDA 510(k) clearance for the geko(TM) Plus R-2 Neuromuscular Stimulator. 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 8, 2016, 64 days after receiving the submission on February 4, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K160299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2016 |
| Decision Date | April 08, 2016 |
| Days to Decision | 64 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 |