Clearance Summary
geko T-2 Neuromuscular Stimulator received FDA 510(k) clearance under submission number K152677, sponsored by Firstkind Limited. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2015-10-23.
- Submission: K152677
- Applicant / Sponsor: Firstkind Limited
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2015-10-23
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.