Cleared Special

K243572 - Game Ready system (550500-04) (FDA 510(k) Clearance)

Also includes:
Game Ready Control Unit (550550-04) Game Ready Full Leg Boot Wrap - Medium (590923-04) Game Ready Full Leg Boot Wrap - Large (590922-04) Game Ready C-T Spine Wrap (590502-04) Game Ready Half Leg Boot (590906-04) Game Ready Back Wrap (590500-04) Game Ready Hand/Wrist Wrap (590811-04) Game Ready Flexed Elbow Wrap (590903-04) Game Ready Straight Elbow Wrap (590200-04) Game Ready Shoulder Wrap, Medium, Right (590422-04) Game Ready Shoulder Wrap, La

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

K243572 · Avanos Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
74d
Days
Class 2
Risk

K243572 is an FDA 510(k) clearance for the Game Ready system (550500-04). Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Avanos Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on January 31, 2025 after a review of 74 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 Avanos Medical, Inc. devices

Submission Details

510(k) Number K243572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2024
Decision Date January 31, 2025
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
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 Peers - IRP Massager, Powered Inflatable Tube

All 149
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K243572.
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AIR COMPRESSION BOOTS 1018195,1018196
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