FDA UDI
In Commercial Distribution
🇺🇸 United States
Biometrics Ltd FP3 ForcePlate (0-100 Kg)
DI: 05060481690089
·
Model: FP3
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BIOMETRICS LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Biometrics Ltd FP3 ForcePlate (0-100 Kg)
- Primary DI
- 05060481690089
- Version / Model
- FP3
- Company Name
- BIOMETRICS LIMITED
- Labeler DUNS
- 519969810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-10
- Public Version
- 2
- Public Version Date
- 2018-08-10
- Public Version Status
- Update
- Public Device Record Key
- 58a5d19c-0058-43d9-b4ca-a30afa17aa14
Device Description
Each ForcePlate consists of a sandwich of 2 uniform precision metal plates, with 4 load cells mounted between them. The vertical component of the total reaction force is measured independent of where it is applied over the surface of the plates. The relative light weight and small geometry of the plates aids in a wide range of upper and lower limb applications. The ForcePlates measure as little as the touch of a finger through to full standing weight bearing. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ION | Exerciser, Non-Measuring | Physical Medicine | 890.5370 | 1 |
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43114 | Posturography system platform | A device that is a component of a balance/mobility management system equipped with built-in sensors, transducer and/or force plates that register movement of the patient when he/she adjusts his/her centre of gravity (COG) alignment according to the doctor's instructions, or, the platform provokes destabilizing perturbations and the output of these movements are measured and recorded to the system computer. It is used, e.g., for motor control test (MCT), posture studies, balance, mobility training, and/or sense of equilibrium studies. The patient will stand on this device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060481690089 | GS1 |