Cleared Special

K243791 - Air Pressure Therapy System (FDA 510(k) Clearance)

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

K243791 · Xiamen Weiyou Intelligent Technology Co., Ltd. · Physical Medicine device
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Jan 2025
Decision
34d
Days
Class 2
Risk

K243791 is an FDA 510(k) clearance for the Air Pressure Therapy System. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Xiamen Weiyou Intelligent Technology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on January 13, 2025 after a review of 34 days - a notably fast clearance cycle.

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. Low regulatory complexity 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 Xiamen Weiyou Intelligent Technology Co., Ltd. devices

Submission Details

510(k) Number K243791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2024
Decision Date January 13, 2025
Days to Decision 34 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
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 Consultant

Shanghai SUNGO Management Consulting Co., Ltd.
Ariel Xiang

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 149
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