Cleared Traditional

K192358 - Pressure Therapy System PT1003

K192358 is the FDA 510(k) clearance for Pressure Therapy System PT1003 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 238-day FDA review.

K192358 · Xiamen Senyang Co., Ltd. · Physical Medicine device
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Apr 2020
Decision
238d
Days
Class 2
Risk

K192358 is an FDA 510(k) clearance for the Pressure Therapy System PT1003. 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 April 23, 2020 after a review of 238 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 K192358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2019
Decision Date April 23, 2020
Days to Decision 238 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
123d slower than avg
Panel avg: 115d · This submission: 238d
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 Consultant

Shanghai Sungo Management Consultanting Co., Ltd.
Raymond Luo

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.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 96
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K192358.
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