Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the brace for custom fitting. This product is ideal for knee ligament damage, knee surgeries, and instability of the knee. The ManaEZ Rom Elite is designed for post-operative fixation, allowing the doctor to lock the patient into extension and control range of motion as prescribed. ManaEZ ROM Elite is a quick fitting, universal, telescoping, and drop lock post op knee brace. The brace has a unique malleable bar system to conform to all shapes and sizes. -Telescoping and malleable hinge bars extendable from 16.5" - 27" (42cm - 68.5cm) -Hinge range of motion adjustment: Flexion (0° - 120°) and extension (0° - 90°) -Quick lock key offers ability to control and lock out the hinge motion to 0°, 15°, and 30° directly -Lightweight, latex free breathable material -Easy application, universal size with hook and buckle closure, design fits either leg FDA UDI
- Model / Reference
- ManaEZ ROM Elite Short FDA UDI
- Description
- The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the brace for custom fitting. This product is ideal for knee ligament damage, knee surgeries, and instability of the knee. The ManaEZ Rom Elite is designed for post-operative fixation, allowing the doctor to lock the patient into extension and control range of motion as prescribed. ManaEZ ROM Elite is a quick fitting, universal, telescoping, and drop lock post op knee brace. The brace has a unique malleable bar system to conform to all shapes and sizes. -Telescoping and malleable hinge bars extendable from 16.5" - 27" (42cm - 68.5cm) -Hinge range of motion adjustment: Flexion (0° - 120°) and extension (0° - 90°) -Quick lock key offers ability to control and lock out the hinge motion to 0°, 15°, and 30° directly -Lightweight, latex free breathable material -Easy application, universal size with hook and buckle closure, design fits either leg FDA UDI
Identifiers
- Catalog Number
- EZRS1833 FDA UDI
- Primary DI / UDI-DI
- 00810113680668 FDA UDI
- FDA Product Code
- ITQ FDA UDI
- GMDN Term
- Knee support orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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: Knee support orthosis
ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
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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 5dc0f5ea-0dfe-4e48-8af6-3f1082b5b96f 35 fields · synced Jun 8, 2026