microfet2

GUDID 00850002429008

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.

Hoggan Scientific L.L.C.

Dynamometer force gauge

• Primary Device ID: 00850002429008
• NIH Device Record Key: 8877a812-0bd7-42b9-8318-6bb8185e7381
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microfet2
• Version Model Number: 5021
• Company DUNS: 078431102
• Company Name: Hoggan Scientific L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002429008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162412

FDA Product Code

• LBB: Dynamometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-03
• Device Publish Date: 2025-02-21