K-number	K243791
Device name	Air Pressure Therapy System
Applicant	Xiamen Weiyou Intelligent Technology Co., Ltd.
Product code	IRP
Device class	Class II
Decision date	Jan 13, 2025
Decision	Substantially Equivalent
Regulation	890.5650

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Air Pressure Therapy System is a powered inflatable tube massager intended to temporarily relieve minor muscle aches and pains and temporarily increase circulation to treated areas in people who are in good health. It is an over-the-counter device.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Air Pressure Therapy System

Everything you need for a 510(k) submission. Nothing you don't.