Cleared Special

K013770 - MODIFICATION TO: WINNER ST-2 STIMULATOR

K013770 is the FDA 510(k) clearance for MODIFICATION TO: WINNER ST-2 STIMULATOR by Rich-Mar Corp.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Special 510(k) pathway after a 66-day FDA review.

K013770 · Rich-Mar Corp. · Physical Medicine device
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Jan 2002
Decision
66d
Days
Class 2
Risk

K013770 is an FDA 510(k) clearance for the MODIFICATION TO: WINNER ST-2 STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on January 18, 2002 after a review of 66 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.

View all Rich-Mar Corp. devices

Submission Details

510(k) Number K013770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date January 18, 2002
Days to Decision 66 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
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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 Peers - IPF Stimulator, Muscle, Powered

All 156
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K013770.
NEUROTECH MEDISTIM PLUS, TYPE 291
K014019 · Bio-Medical Research, Ltd. · Jul 2002
APEX MEDICAL DIGITAL EMS TS1311, TS1312
K021754 · Apex Medical Corp. · Jun 2002
300 PV COMPLETE ELECTROTHERAPY SYSTEM
K021100 · Empi · Jun 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K013771 · Rich-Mar Corp. · Jan 2002
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
K010749 · Biomedical Life Systems, Inc. · Sep 2001
AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600
K002339 · Apex Medical Corp. · Aug 2001