Cleared Traditional

K171071 - StimSox(TM) System

K171071 is an FDA 510(k) clearance for StimSox(TM) System, manufactured by Stimmed, LLC. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K171071 · Stimmed, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
121d
Days
Class 2
Risk

K171071 is an FDA 510(k) clearance for the StimSox(TM) System. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Stimmed, LLC (Williamsville, US). The FDA issued a Cleared decision on August 9, 2017 after a review of 121 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.

FDA 510(k) Submission Details - K171071

510(k) Number K171071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2017
Decision Date August 09, 2017
Days to Decision 121 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
5d slower than avg
Panel avg: 116d · This submission: 121d
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 Consultant

Wright Regulatory Consulting, Inc.
Marlene Wright Barton

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 370
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K171071.
Digitimer DS7AP Constant Current Stimulator
K172381 · Digitimer , Ltd. · Mar 2018
geko T-2 and geko Plus R-2
K180082 · Firstkind, Ltd. · Feb 2018
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978 · Shenzhen Dongdixin Technology Co., Ltd. · Oct 2017
EMS100 Tri-Wave Combination Stimulator
K171387 · Elite Medical Supply of New York, LLC · May 2017
geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators
K163125 · Firstkind Limited · Apr 2017
FA100 SCCD (Sequential Continuous Contraction Device)
K162987 · Flowaid Medical Technologies, Corp · Feb 2017