Cleared Traditional

K161907 - Pressure Therapy System

K161907 is the FDA 510(k) clearance for Pressure Therapy System by Xiamen Senyang Co., Ltd.. It is a Class 2 Physical Medicine device (product code IRP) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K161907 · Xiamen Senyang Co., Ltd. · Physical Medicine device
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Feb 2017
Decision
226d
Days
Class 2
Risk

K161907 is an FDA 510(k) clearance for the Pressure Therapy System. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Xiamen Senyang Co., Ltd. (Xinglin Xiamen, CN). The FDA issued a Cleared decision on February 23, 2017 after a review of 226 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 Xiamen Senyang Co., Ltd. devices

Submission Details

510(k) Number K161907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2016
Decision Date February 23, 2017
Days to Decision 226 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 115d · This submission: 226d
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 97
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K161907.
Pulse 2.0, Pulse Pro 2.0
K183169 · NormaTec Industries, LP · Dec 2018
Rapid Reboot Compression Therapy System
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Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
K181149 · Zenith Technical Innovations · Aug 2018
INTERMITTENT COMPRESSION PUMPS
K832920 · Chattanooga Group, Inc. · Nov 1983