microfet2

Basic Information

• Brand Name: microfet2
• Primary DI: 00850002429008
• Version / Model: 5021
• 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: 2025-02-21
• Public Version: 1
• Public Version Date: 2025-03-03
• Public Version Status: New
• Public Device Record Key: 8877a812-0bd7-42b9-8318-6bb8185e7381

Device Description

microFET®2 is a hand-held dynamometer (HHD) for performing muscle tests to quantitatively measure muscle weakness caused by injury, as well as measure general muscle strength. The device is used to convey an individual’s ability to resist force for a specific muscle or muscle group being tested.

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: No
• 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	00850002429008	GS1

Premarket Submissions

Submission Number	Supplement Number
K162412	000