K212762 is an FDA 510(k) clearance for the geko W-2. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.
Submitted by Firstkind Limited (High Wycombe, GB). The FDA issued a Cleared decision on November 29, 2021 after a review of 90 days - within the typical 510(k) review window.
This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.
View all Firstkind Limited devices
NCT02482038
Completed
Interventional
Industry-sponsored
Geko Venous Leg Ulcer Study
A Single Centre Open Label Pilot Study Measuring Lower Limb Blood Flow in Patients With Venous Leg Ulcers Using the Geko™ T-2 or gekoTM Plus [R-2] Neuromuscular Electro Stimulation Device
| Condition studied |
Venous Leg Ulcer |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Sponsor |
Firstkind Ltd
(industry)
|
Started 2016-09-01
→
Primary completion 2018-06-05
→
Completed 2019-10-10
Primary outcome
Ultra sound measurements of haemodynamics
Secondary outcome
Adverse event rate
Study completed - no results published.
This trial concluded in 2019 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov