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
K243572 · Avanos Medical, Inc. · Physical Medicine device
Jan 2025
Decision
74d
Days
Class 2
Risk

K243572 is an FDA 510(k) clearance for the Game Ready system (550500-04). This device is classified as 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 FDA review panel. Regulated under 21 CFR 890.5650.

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

Device Classification

Product Code IRP - Massager, Powered Inflatable Tube
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.5650