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Cold Compression Powered Inflatable Tube Massager

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240986

by JKH Health Co., Ltd.

Identifiers

510(k) Number
K240986 FDA 510(k)
FDA Product Code
IRP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5650 FDA 510(k)
Regulation Number
890.5650 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Powered Inflatable Tube Massager, classified as a Class II medical device under 21 CFR 890.5650. It delivers controlled cold compression therapy to reduce edema, swelling, and pain associated with post-surgical or acute injuries, as well as to aid venous return in lower extremity conditions.

The device is intended for single-use or reusable applications in clinical settings, with inflatable tubes designed for adjustable compression. It has received FDA 510(k) clearance under the Special 510(k) Review Process and is regulated under the Physical Medicine advisory committee. Multiple registration numbers (e.g., 3012184077) correspond to its regulatory filing, and it adheres to MRI safety standards for powered inflatable tubes.

Frequently asked questions

What clinical conditions is this cold compression device primarily designed to address?

This device is designed to deliver controlled cold compression therapy for reducing edema, swelling, and pain associated with post-surgical recovery or acute injuries. It also aids venous return in lower extremity conditions, helping manage discomfort and fluid accumulation in those areas.

Is this device intended for single-use or reusable applications, and how does that affect its clinical use?

The device is explicitly designed for both single-use and reusable applications in clinical settings. This flexibility allows facilities to choose based on infection control protocols, patient volume, and cost considerations—whether to use it once per patient or clean and reuse it after proper disinfection.

What sizes or models of inflatable tubes are available for this cold compression device?

The device includes adjustable inflatable tubes, though specific sizes or model variants (e.g., upper/lower extremity, circumference ranges) are not detailed in the provided data. Clinicians should confirm the exact tube dimensions or compatibility with their patient population by reviewing the manufacturer’s technical specifications or contacting JKH Health Co., Ltd.

How should this device be stored to maintain its performance and safety?

While the data does not specify storage conditions, powered inflatable tubes like this typically require protection from extreme temperatures, moisture, and physical damage. The manufacturer’s instructions (not provided here) would outline ideal storage—likely a clean, dry environment away from direct sunlight or sources of contamination—to preserve functionality and ensure MRI safety compliance.

What regulatory pathway was followed for FDA clearance, and how does that affect its use in clinical settings?

The device received FDA 510(k) clearance under the Special 510(k) Review Process, classified as a Class II medical device under 21 CFR 890.5650. This means it was deemed *substantially equivalent* to a predicate device and is regulated under the Physical Medicine advisory committee. Clinicians can rely on this clearance for confidence in its safety and performance, though local protocols for cold therapy application should still be followed.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K240986 FDA 510 (k) - Cold Compression | Jkh Health Co., Ltd., PDF Bill Quanqin Dai Managing Member Trade/Device Name: Cold Compression ..., PDF October 24, 2025 JKH Health Co., Ltd. - accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
JKH Health Co., Ltd.

Sources (1)

  • FDA 510(k) K240986 24 fields · synced Sep 19, 2026