Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- ManaOA is a lightweight, low-profile single upright osteoarthritis knee brace with unique varus/valgus angle adjustment to optimize pain relief. Laterally applied frame and hinge corrects for either medial or lateral compartment and avoids contralateral limb contact during walking. Indication: Mild to severe unicompartmental osteoarthritis, Medial or lateral compartment Features & Benefits: Single upright OA brace. Set-Fit Buckle System that eliminates the hassle of Velcro® adjustments. Maximized 3 points of leverage for medical compartment. Q-Hinge corrects by changing the overall angle of the brace rather than pushing or pulling with the straps or condyle pads. Available in heavy-duty Q-hinge for patients over 300 pounds. FDA UDI
- Model / Reference
- ManaForce, RT, LFT FDA UDI
- Description
- ManaOA is a lightweight, low-profile single upright osteoarthritis knee brace with unique varus/valgus angle adjustment to optimize pain relief. Laterally applied frame and hinge corrects for either medial or lateral compartment and avoids contralateral limb contact during walking. Indication: Mild to severe unicompartmental osteoarthritis, Medial or lateral compartment Features & Benefits: Single upright OA brace. Set-Fit Buckle System that eliminates the hassle of Velcro® adjustments. Maximized 3 points of leverage for medical compartment. Q-Hinge corrects by changing the overall angle of the brace rather than pushing or pulling with the straps or condyle pads. Available in heavy-duty Q-hinge for patients over 300 pounds. FDA UDI
Identifiers
- Catalog Number
- MFORCE02L FDA UDI
- Primary DI / UDI-DI
- 00810113681559 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
- 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 3d98b991-37c8-406a-bdff-0aaaaeda3099 36 fields · synced Jun 1, 2026