Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Compression/pressure tubular garment FDA UDI
- Device Name
- ManaEZ Hip Ice is a quick fitting, universal, hip range of motion orthosis. The brace includes range of motion hinges to allow for flexion and extension control. A quick inflation system that can improve outcomes by managing pain and swelling. This hip brace also includes two high quality ice packs. Quick fitting Cold compression Range of motion hinge Universally sized FDA UDI
- Model / Reference
- ManaEZ Compression Hip Ice FDA UDI
- Description
- ManaEZ Hip Ice is a quick fitting, universal, hip range of motion orthosis. The brace includes range of motion hinges to allow for flexion and extension control. A quick inflation system that can improve outcomes by managing pain and swelling. This hip brace also includes two high quality ice packs. Quick fitting Cold compression Range of motion hinge Universally sized FDA UDI
Identifiers
- Catalog Number
- EZIWH01B FDA UDI
- Primary DI / UDI-DI
- 00810113680507 FDA UDI
- FDA Product Code
- ITS FDA UDIIRP FDA UDI
- GMDN Term
- Compression/pressure tubular garment FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 FDA UDI890.5650 FDA UDI
- Commercial Distribution
- Not 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
ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 60fbbcbc-dd73-453e-94b4-b68ff800f875 36 fields · synced Jun 1, 2026