Cleared Special

K171387 - EMS100 Tri-Wave Combination Stimulator

K171387 is an FDA 510(k) clearance for EMS100 Tri-Wave Combination Stimulator, manufactured by Elite Medical Supply of New York, LLC. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Special 510(k) pathway after a 20-day FDA review.

K171387 · Elite Medical Supply of New York, LLC · Physical Medicine device
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May 2017
Decision
20d
Days
Class 2
Risk

K171387 is an FDA 510(k) clearance for the EMS100 Tri-Wave Combination Stimulator. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Elite Medical Supply of New York, LLC (West Seneca, US). The FDA issued a Cleared decision on May 31, 2017 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K171387

510(k) Number K171387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2017
Decision Date May 31, 2017
Days to Decision 20 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 116d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 370
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K171387.
geko T-2 and geko Plus R-2
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geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators
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