Cleared Traditional

geko T-2 and geko Plus R-2 (K180082) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180082 · Firstkind, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
31d
Days
Class 2
Risk

K180082 is an FDA 510(k) clearance for the geko T-2 and geko Plus R-2. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Firstkind, Ltd. (High Wycombe, GB). The FDA issued a Cleared decision on February 11, 2018 after a review of 31 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Firstkind, Ltd. devices

Submission Details

510(k) Number K180082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2018
Decision Date February 11, 2018
Days to Decision 31 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Heyer Regulatory Solutions, LLC
Sheila Hemeon-Heyer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 73
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K180082.
R-C1 TENS and EMS Stimulator
K181688 · Shenzhen Roundwhale Technology Co. , Ltd. · Sep 2018
geko T-3 Neuromuscular Stimulator
K181059 · Firstkind Limited · May 2018
Digitimer DS7AP Constant Current Stimulator
K172381 · Digitimer , Ltd. · Mar 2018
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978 · Shenzhen Dongdixin Technology Co., Ltd. · Oct 2017
HPM-6000
K160992 · BTL Industries, Inc. · Oct 2016
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001