Cleared Traditional

K133638 - GEKO

K133638 is an FDA 510(k) clearance for GEKO, manufactured by Firstkind Limited. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K133638 · Firstkind Limited · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
267d
Days
Class 2
Risk

K133638 is an FDA 510(k) clearance for the GEKO. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Firstkind Limited (West Boylston, US). The FDA issued a Cleared decision on August 21, 2014 after a review of 267 days - an extended review 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: 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

FDA 510(k) Submission Details - K133638

510(k) Number K133638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2013
Decision Date August 21, 2014
Days to Decision 267 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
151d slower than avg
Panel avg: 116d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

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 Peers - IPF Stimulator, Muscle, Powered

All 299
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K133638.
Muscle Stimulation System 110
K150742 · Niveus Medical, Inc. · Jul 2015
QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
K150413 · Cymedica Orthopedics, Inc. · Apr 2015
FLEX-MT +
K140467 · Emsi · Oct 2014
NEURODYN COMPACT, NEURODYN II
K131917 · Ibramed Equipamentos Medicos · Apr 2014
VECTRA NEO CLINICAL THERAPY SYSTEM
K132284 · Djo, LLC · Apr 2014
TONE-A-MATIC
K130052 · Tone-A-Matic International, Inc. · Dec 2013