Cleared Special

K160178 - Lympha-Flow(LF1200) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K160178 · Daesung Maref Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 115d · This submission: 350d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Peers - IRP Massager, Powered Inflatable Tube

All 149
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K160178.
Air Pressure Therapy System (VU-IPC8M)
K253064 · Xiamen Weiyou Intelligent Technology Co., Ltd. · Apr 2026
Hot and Cold Compression System (A02-C-032)
K252386 · Chengdu Cryo-Push Medical Technology Co.,Ltd · Apr 2026
Cryopush Cold Compression Device (A02-P-001)
K253076 · Chengdu Cryo-Push Medical Technology Co.,Ltd · Apr 2026
Hand Massager (SM004D)
K251622 · Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. · Jan 2026
Air Compression Therapy Device (ST-504)
K251662 · Shenzhen Future Electronic Co., Ltd. · Nov 2025
AIR COMPRESSION BOOTS 1018195,1018196
K251531 · Merchsource, LLC · Oct 2025