Cleared Traditional

K171978 - Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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

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