The following data is part of a premarket notification filed by Firstkind Limited with the FDA for Geko(tm) Plus R-2 Neuromuscular Stimulator.
| Device ID | K160299 |
| 510k Number | K160299 |
| Device Name: | Geko(TM) Plus R-2 Neuromuscular Stimulator |
| 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 | 2016-02-04 |
| Decision Date | 2016-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060294770749 | K160299 | 000 |