FDA UDI
In Commercial Distribution
🇺🇸 United States
Biometrics Ltd Dynamometer
DI: 05060481692403
·
Model: G100
·
BIOMETRICS LIMITED
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Biometrics Ltd Dynamometer
- Primary DI
- 05060481692403
- Version / Model
- G100
- Company Name
- BIOMETRICS LIMITED
- Labeler DUNS
- 519969810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-09
- Public Version
- 1
- Public Version Date
- 2018-09-10
- Public Version Status
- New
- Public Device Record Key
- 9d577c90-3649-4303-ba87-760e28e04665
Device Description
The Biometrics Dynamometer utilises precision load cell technology to increase the sensitivity and accuracy of measurement of even very low grip strength forces. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
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 |
|---|---|---|---|---|
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
| IKK | System, Isokinetic Testing And Evaluation | Physical Medicine | 890.1925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33785 | Hand dynamometer/pinchmeter, electronic | An electrically-powered instrument designed to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. It is used to assess a patient's grip strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke; it may in addition be designed to be used as part of an interactive rehabilitation system whereby forces applied by the patient translate to movements in a video-game. It includes a force transducer to translate force into electrical impulses for measurement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060481692403 | GS1 |