FDA UDI
In Commercial Distribution
🇺🇸 United States
ManaMed
DI: 00810113681573
·
Model: ManaForceOA, LFT
·
MANAMED INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ManaMed
- Primary DI
- 00810113681573
- Version / Model
- ManaForceOA, LFT
- Catalog Number
- MFORCEOA1L
- Company Name
- MANAMED INC
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-23
- Public Version
- 2
- Public Version Date
- 2022-08-30
- Public Version Status
- Update
- Public Device Record Key
- 612dd0de-e496-4e1d-911f-1b93235191ac
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41065 | Knee support orthosis | A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810113681573 | GS1 |
Customer Contacts
- Phone
- 888-508-0712
- [email protected]