Cleared Special

K160178 - Lympha-Flow(LF1200)

K160178 is an FDA 510(k) clearance for Lympha-Flow(LF1200), manufactured by Daesung Maref Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Special 510(k) pathway after a 350-day FDA review.

K160178 · Daesung Maref Co., Ltd. · Physical Medicine device
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Jan 2017
Decision
350d
Days
Class 2
Risk

K160178 is an FDA 510(k) clearance for the Lympha-Flow(LF1200). Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Daesung Maref Co., Ltd. (Gunpo-Si, KR). The FDA issued a Cleared decision on January 11, 2017 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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. Elevated predicate reliance 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 Daesung Maref Co., Ltd. devices

FDA 510(k) Submission Details - K160178

510(k) Number K160178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date January 11, 2017
Days to Decision 350 days
Submission Type Special
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
234d slower than avg
Panel avg: 116d · This submission: 350d
Pathway characteristics
Modification to existing cleared device.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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

Mtechgroup
Dave Kim

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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