Game Ready system (550500-04) +11 more— 510(k) K243572
Substantially EquivalentAvanos Medical, Inc.
FDA 510(k) clearance K243572 for Game Ready system (550500-04) +11 more, Substantially Equivalent on 2025-01-31. Applicant: Avanos Medical, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 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
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alpharetta, GA, US
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More clearances from Avanos Medical, Inc.
view all- K241185 — CORGRIP* SR NG/NI Tube Retention System
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- K240965 — CORTRAK* 2 Enteral Access System (20-0950)
- K220588 — Avanos* CORTRAK* 2 Enteral Access System (EAS)
- K203066 — COOLIEF Cooled Radiofrequency Kit Advanced
Data sourced from openFDA. This site is unofficial and independent of the FDA.