Cleared Special

Game Ready system (550500-04); 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

K243572 · Avanos Medical, Inc. · Physical Medicine

Jan 2025

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K243572 is an FDA 510(k) clearance for the Game Ready system (550500-04); 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, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Avanos Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on January 31, 2025, 74 days after receiving the submission on November 18, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number	K243572 FDA.gov
FDA Decision	Cleared 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