Cleared Traditional

K171978 - Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

K171978 is an FDA 510(k) clearance for Combo Stimulator MT9000, manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K171978 · Shenzhen Dongdixin Technology Co., Ltd. · Physical Medicine device
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Oct 2017
Decision
94d
Days
Class 2
Risk

K171978 is an FDA 510(k) clearance for the Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 2, 2017 after a review of 94 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.

View all Shenzhen Dongdixin Technology Co., Ltd. devices

FDA 510(k) Submission Details - K171978

510(k) Number K171978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2017
Decision Date October 02, 2017
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
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 257
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K171978.
geko T-3 Neuromuscular Stimulator
K181059 · Firstkind Limited · May 2018
Digitimer DS7AP Constant Current Stimulator
K172381 · Digitimer , Ltd. · Mar 2018
geko T-2 and geko Plus R-2
K180082 · Firstkind, Ltd. · Feb 2018
StimSox(TM) System
K171071 · Stimmed, LLC · Aug 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