Cleared Traditional

LF900 (K203019) - FDA 510(k) Clearance

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

K203019 · Daesung Maref Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
264d
Days
Class 2
Risk

K203019 is an FDA 510(k) clearance for the LF900. 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 June 22, 2021 after a review of 264 days - an extended review cycle.

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

Submission Details

510(k) Number K203019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2020
Decision Date June 22, 2021
Days to Decision 264 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
149d slower than avg
Panel avg: 115d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 95
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K203019.
V12 PRO
K210913 · Slk Medical GmbH · Aug 2021
LX9max
K203498 · Daesung Maref Co., Ltd. · Jul 2021
Air Pressure Therapy System
K201935 · Xiamen Weiyou Intelligent Technology Co., Ltd. · Jun 2021
Fist Assist Devices Model FA-1
K210281 · Fist Assist Devices, LLC · Jun 2021
Air Relax Plus Model AR-3.0
K211460 · Diode Art Engineering Doing Business AS Air Relax · May 2021
Air Pressure Therapy System: VU-IPC06
K210967 · Xiamen Weiyou Intelligent Technology Co., Ltd. · May 2021