FDA UDI
In Commercial Distribution
🇺🇸 United States
microfet3
DI: 00850002429312
·
Model: 5026
·
Hoggan Scientific L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- microfet3
- Primary DI
- 00850002429312
- Version / Model
- 5026
- Company Name
- Hoggan Scientific L.L.C.
- Labeler DUNS
- 078431102
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-24
- Public Version
- 1
- Public Version Date
- 2025-03-04
- Public Version Status
- New
- Public Device Record Key
- 213d1692-695a-4171-aa42-3c8ef777d182
Device Description
The microFET®3 is a dynamometer device for performing muscle tests to quantitatively measure muscle weakness caused by injury or disease, as well as measure general muscle strength. The device is used to record and convey an individual's ability to resist force for a specific muscle or muscle group being tested. Range of motion tests to quantitatively measure the angle of the body segment or joint tested to determine an individual's range of motion referenced from body's natural position.
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
- 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 |
|---|---|---|---|---|
| LBB | Dynamometer, Ac-Powered | Orthopedic | 888.1240 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63454 | Dynamometer force gauge | An electrically-powered component of a digital (electric) dynamometer intended to measure and display and/or communicate forces during assessment of neuromuscular function. It is a small unit with a built-in force sensor and is intended to be used with an appropriate dynamometer attachment(s); it is not a complete dynamometer. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850002429312 | GS1 |