Cleared Traditional

Compressible Limb and Circulation Therapy System, Model POWER-Q2300 (K211283) - FDA 510(k) Clearance

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

K211283 · Wonjin Mulsan Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
140d
Days
Class 2
Risk

K211283 is an FDA 510(k) clearance for the Compressible Limb and Circulation Therapy System, Model POWER-Q2300. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Wonjin Mulsan Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on September 14, 2021 after a review of 140 days - within the typical 510(k) review window.

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 Wonjin Mulsan Co., Ltd. devices

Submission Details

510(k) Number K211283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2021
Decision Date September 14, 2021
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
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 K211283.
Air compression therapy system FO3002
K212169 · Foshan Hongfeng Co., Ltd. · Nov 2021
Air Compression Massager (Model LF-FT003)
K213000 · Wenzhou Lingfeng Electronic Technology Co., Ltd. · Nov 2021
RecoveryAir PRO
K211745 · Theragun, Inc. · Oct 2021
Air Relax Pro Model AR-4.0
K212491 · Diode Art Engineering Doing Business AS Air Relax · Sep 2021
SP-1000, SP-2000
K202395 · Daesung Maref Co., Ltd. · Sep 2021
V12 PRO
K210913 · Slk Medical GmbH · Aug 2021