The following data is part of a premarket notification filed by Firstkind Limited with the FDA for Geko W-3.
| Device ID | K220327 |
| 510k Number | K220327 |
| Device Name: | Geko W-3 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Firstkind Limited Hawk House, Peregrine Business Park High Wycombe, GB Hp13 7dl |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-04 |
| Decision Date | 2022-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060294771609 | K220327 | 000 |