Identity
- Trade Name
- Game Ready FDA UDI
- Generic Name
- Circulating-fluid localized thermal/compression therapy system control unit FDA UDI
- Device Name
- Game Ready Every Athlete Program, Runner's Edition FDA UDI
- Model / Reference
- 552725 FDA UDI
- Description
- Game Ready Every Athlete Program, Runner's Edition FDA UDI
Identifiers
- Catalog Number
- 552725 FDA UDI
- Primary DI / UDI-DI
- 00812120003256 FDA UDI
- 510(k) Number
- K192114 FDA UDI
- FDA Product Code
- IRP FDA UDIILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal/compression therapy system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 FDA UDI890.5720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Circulating-fluid localized thermal/compression therapy system control unit
Game Ready by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192114 also covers:
- Game Ready — Avanos Medical, Inc.
- Game Ready — Avanos Medical, Inc.
- Game Ready — Avanos Medical, Inc.
- Game Ready — Avanos Medical, Inc.
- Game Ready — Avanos Medical, Inc.
- Game Ready — Avanos Medical, Inc.
- Game Ready — Avanos Medical, Inc.
- Game Ready — Avanos Medical, Inc.
- Game Ready — Avanos Medical, Inc.
- Game Ready 2.1 System China — Avanos Medical, Inc.
- Game Ready Ankle Heat Exchanger - Large- Rental — Avanos Medical, Inc.
- Game Ready Ankle Wrap - Extra Large - Demo — Avanos Medical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI a1abdb39-6496-4eb8-9b4c-fc5a6f17f5c5 36 fields · synced Jun 9, 2026