Identity
- Trade Name
- Aquilo Sports FDA UDI
- Generic Name
- Circulating-fluid localized thermal/compression therapy system wrap FDA UDI
- Model / Reference
- Full Leg Sleeve (L) - Left FDA UDI
Identifiers
- Catalog Number
- AQU669 CL2 FDA UDI
- Primary DI / UDI-DI
- 00850009827388 FDA UDI
- 510(k) Number
- K223164 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Circulating-fluid localized thermal/compression therapy system wrap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 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
No
FDA UDI
Over-the-Counter
Yes
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
No
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 wrap
Aquilo Sports by Aquilo Sports L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Circulating-fluid localized thermal/compression therapy system wrap.
- Game Ready — Avanos Medical, Inc. · Class II
- Game Ready — Avanos Medical, Inc. · Class II
- Game Ready — Avanos Medical, Inc. · Class II
- Game Ready Left Shoulder Heat Exchanger, Rental — Avanos Medical, Inc. · Class II
- Game Ready Full Leg Boot Wrap - Medium - Rental — Avanos Medical, Inc. · Class II
- Game Ready Med4 Elite Power Cord — Avanos Medical, Inc. · Class II
- Game Ready — Avanos Medical, Inc. · Class II
- Game Ready — Avanos Medical, Inc. · Class II
Cleared under the same submission
K223164 also covers:
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aquilo Sports L.l.c.
Sources (1)
- FDA UDI 880903a6-9fa4-429b-a310-55a59911e38b 34 fields · synced Jun 8, 2026