K243572
- 510(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. GA · US
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2025-01-31
- Date received
- 2024-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243572
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.