Cleared Traditional

K100117 - LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR

K100117 is an FDA 510(k) clearance for LT3000 COMBO STIMULATOR, 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 14-day FDA review.

K100117 · Shenzhen Dongdixin Technology Co., Ltd. · Physical Medicine device
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Jan 2010
Decision
14d
Days
Class 2
Risk

K100117 is an FDA 510(k) clearance for the LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Nanshan District, Shenzhen, CN). The FDA issued a Cleared decision on January 29, 2010 after a review of 14 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Dongdixin Technology Co., Ltd. devices

FDA 510(k) Submission Details - K100117

510(k) Number K100117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2010
Decision Date January 29, 2010
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Underwriters Laboratories, Inc.
MARC M MOUSER

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.

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FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.