Avanos Medical, Inc. · Class II · Cleared Jan 31, 2025
| K-number | K243572 |
| Device name | 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 |
| Applicant | Avanos Medical, Inc. |
| Product code | IRP |
| Device class | Class II |
| Decision date | Jan 31, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.5650 |
The Game Ready system is a powered inflatable massage device indicated for temporary relief of minor muscle aches and pains, temporary increase in circulation, and localized cold temperature therapy. It consists of a control unit and multiple interchangeable wraps for different body areas (legs, back, spine, arms, shoulders, hips, knees, and ankles) that simulate kneading and stroking of tissues using inflatable technology.
Not stated in this summary.
Not stated in this summary.
Not stated in this summary. The document confirms the device is substantially equivalent to legally marketed predicate devices or reclassified devices, but does not disclose the specific predicate device, technological comparison basis, or the reasoning supporting the substantial equivalence determination.
View the full FDA submission: accessdata.fda.gov