Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Hot/cold therapy pack, reusable FDA UDI
- Device Name
- The ManaEZ Shoulder ice a convenient shoulder orthosis for pain, swelling, and to compress the shoulder joint. Pump up with air and compress the cold to alleviate pain faster. Removable gel liner for cooling in freezer. Drip free fabric to allow breathing. Easy to apply over clothing. Can be used for sprains, sports injuries, rehab, arthritis, and muscle tensions / fatigues. FDA UDI
- Model / Reference
- ManaEZ Shoulder Ice FDA UDI
- Description
- The ManaEZ Shoulder ice a convenient shoulder orthosis for pain, swelling, and to compress the shoulder joint. Pump up with air and compress the cold to alleviate pain faster. Removable gel liner for cooling in freezer. Drip free fabric to allow breathing. Easy to apply over clothing. Can be used for sprains, sports injuries, rehab, arthritis, and muscle tensions / fatigues. FDA UDI
Identifiers
- Catalog Number
- EZSHLD FDA UDI
- Primary DI / UDI-DI
- 00810113680675 FDA UDI
- FDA Product Code
- KYR FDA UDIIQQ FDA UDI
- GMDN Term
- Hot/cold therapy pack, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6050 FDA UDI890.3420 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hot/cold therapy pack, reusableShoulder immobilizer/orthosis, reusable
ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI d0bda748-aab2-4821-acdb-1ced23e74d6c 35 fields · synced Jun 1, 2026