The following data is part of a premarket notification filed by Firstkind Ltd with the FDA for Geko T-2 And Geko Plus R-2.
| Device ID | K180082 |
| 510k Number | K180082 |
| Device Name: | Geko T-2 And Geko Plus R-2 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Firstkind Ltd Hawk House, Peregrine Business Park High Wycombe, GB Hp137dl |
| Contact | Neil Buckley |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-11 |
| Decision Date | 2018-02-11 |
| Summary: | summary |